Ingenuity Flex
Catalogue number 728317, listed by Philips Medical Systems (Cleveland), Inc., United States, under System, X-Ray, Tomography, Computed. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
1catalogue number
24510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Jiangsu (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Philips Healthcare (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| Qisda Electronics (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 5 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Neusoft Medical Systems Co., Ltd. | Shenyang | Liaoning | Manufacturer | 1 |
| Philips Health Technology (China) Co., Ltd. Shenyang Branch | Shenyang | Liaoning | Specification developer | 1 |
Record
| Listed by | Philips Medical Systems (Cleveland), Inc., United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-23 |
| Record revised | 2025-09-16 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2018-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 728317 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Visicoil | IZI Medical Products LLC | 48 |
| Visicoil MR | IZI Medical Products LLC | 41 |
| Illumisite | Covidien LP | 25 |
| Imbio LDA | Imbio, LLC | 24 |
| Edge | Covidien LP | 20 |
| Revolution | GE Hangwei Medical Systems Co., Ltd. | 20 |
| Gold Fiducial | IZI Medical Products LLC | 20 |
| superDimension | Covidien LP | 17 |
| Lodox | Lodox Systems (PTY) Ltd. | 12 |
| Revolution | GE Medical Systems, L.L.C. | 12 |
| Toshiba Scanner | Canon Inc. | 10 |
| syngo.CT Dual Energy | Siemens Healthcare Limited | 7 |
Showing 12 of 495. All products under System, X-Ray, Tomography, Computed
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K171850 | 2017-11-09 |
| K162838 | 2017-04-07 |
| K163711 | 2017-04-05 |
| K160743 | 2016-08-08 |
| K153444 | 2016-04-08 |
| K092747 | 2009-10-09 |
| K090462 | 2009-06-23 |
| K091195 | 2009-05-27 |
| K083498 | 2008-12-17 |
| K060937 | 2006-06-05 |
| K042293 | 2004-09-08 |
| K033677 | 2004-02-20 |
| K033357 | 2004-01-09 |
| K023785 | 2003-02-10 |
| K010817 | 2001-06-15 |
| K001088 | 2000-06-22 |
| K982010 | 1998-11-19 |
| K974513 | 1998-05-20 |
| K955268 | 1996-01-30 |
| K943623 | 1995-04-27 |
| K882378 | 1988-10-11 |
| K801407 | 1980-07-28 |
| K772123 | 1977-11-21 |
| K770855 | 1977-05-26 |
Recalls
40 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 202 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 92 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 27 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 116 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 12 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 582 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 26 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 25 | 2022-10-06 |
| 2019-06-24 | Class II | Other | In certain instances when performing a cardiac step and shoot acquisition with phase tolerance selected, images may be labeled as if phase tolerance had been applied when phase tolerance had not been applied | 128 | 2022-10-06 |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 2021-08-03 | |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 6,343 units in total | 2021-08-03 |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 6,343 units in total | 2021-08-03 |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 6,343 units in total | 2021-08-03 |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 6,343 units in total | 2021-08-03 |
| 2018-10-18 | Class II | Process control | There is a potential for separation of fiberglass resin which may cause the gantry front cover and the metal support on the cover to fail/fall | 6,343 units in total | 2021-08-03 |
| 2018-07-03 | Class II | Device Design | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator b | 14 | 2020-04-17 |
| 2018-07-03 | Class II | Device Design | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator b | 23 | 2020-04-17 |
| 2018-07-03 | Class II | Device Design | Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator b | 2 | 2020-04-17 |
| 2018-03-30 | Class II | Device Design | The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment | 20 | 2020-04-14 |
| 2018-03-30 | Class II | Device Design | The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment | 3 | 2020-04-14 |
| 2018-03-30 | Class II | Device Design | The patient support head holder could contact the back ISO shelter wall during manual or motorized motion through the gantry bore. This may result in a serious injury that would require medical intervention to preclude permanent impairment | 2 | 2020-04-14 |
| 2018-03-28 | Class II | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. | 28 total | 2020-04-21 |
| 2018-03-28 | Class II | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. | 2020-04-21 | |
| 2018-03-28 | Class II | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. | 28 total | 2020-04-21 |
| 2018-03-28 | Class II | Other | A problem has been detected in the X-Ray Tube. The affected tubes have a production defect that allows oil leakage from the tube housing, if it were to re-occur, could pose a risk for patients or users. | 28 total | 2020-04-21 |
| 2018-02-21 | Class II | Under Investigation by firm | Surview scan with tube current lower than 30 mA is unable to be initialized. | 291 | 2020-04-10 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 591 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 119 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 19 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 151 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 47 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 172 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 1 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 2 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 295 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 281 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 6 | 2020-04-09 |
| 2018-02-08 | Class II | Software design | Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities. | 106 | 2020-04-09 |
| 2018-01-11 | Class II | Under Investigation by firm | 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: ” Software errors that may result in CT spectral images misrepresentation or incorrect treatment; ” Software errors that may result in pa | 63 | 2019-05-20 |
| 2018-01-03 | Class II | Under Investigation by firm | Software issues including: Software errors that may result in Extended Field of View check message not displayed when Field of View is set >600 mm for a paused scan; Request for change to automatically turn on the center x/y 0 setting and t | 119 | 2019-07-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.