MiniCAT
The FDA filing identifies MiniCAT as an X-ray imaging device that constructs a three-dimensional model of the head and neck from a rotational X-ray sequence. The device is optimized for…
The FDA filing identifies MiniCAT as an X-ray imaging device that constructs a three-dimensional model of the head and neck from a rotational X-ray sequence.
The device is optimized for imaging the maxillofacial complex, temporal bone, sinuses, and neuro-angiography.
Device Description and Stated Use
The filing describes a 360-degree X-ray image acquisition sequence and software for image acquisition, processing, and viewing. Major hardware components include the X-ray source, scanning arm, and detector.
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 | Xoran Technologies, LLC, United States |
|---|---|
| FDA product code | JAK |
| Device type | System, X-Ray, Tomography, Computed |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1750 |
| Establishment | Remanufacturer, Complaint-file establishment, Manufacturer |
| 510(k) | K113421 |
| Record published | 2016-09-20 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10004 | In distribution |
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 |
|---|---|
| K113421 | 2012-07-11 |
| K061834 | 2006-08-07 |
| K032243 | 2003-10-02 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Xoran Technologies, LLC | 510(k) number | 2014-09-08 | Class II | Radiation Control for Health and Safety Act | Out of tolerance kVp, Unexposed (black) frames, and Out of tolerance Dose. | 432 | 2016-02-02 |
Recalls
6 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 |
|---|---|---|---|---|---|
| 2010-07-27 | Class II | Radiation Control for Health and Safety Act | The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran’s specifications. See ATTACHMENT 1 | 2014-09-11 | |
| 2010-07-27 | Class II | Radiation Control for Health and Safety Act | A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 1 | 320 | 2014-09-11 |
| 2010-07-27 | Class II | Radiation Control for Health and Safety Act | A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of | 320 | 2014-09-11 |
| 2010-07-27 | Class II | Radiation Control for Health and Safety Act | The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications. | 320 | 2014-09-11 |
| 2010-07-27 | Class II | Radiation Control for Health and Safety Act | The MiniCAT CT Scanners subject to this notification failed to meet Xoran’s specifications for dose rate of 125 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran’s specifications. See ATTACHMENT 1 | 320 | 2014-09-11 |
| 2009-12-14 | Class II | Radiation Control for Health and Safety Act | Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. | 320 | 2014-09-11 |
| 2008-09-17 | Not classified | Device Design | The system may overheat, causing poor image quality, interruption in image acquisition and/or damage to the system. Also, if the system is not allowed to cycle down prior to being restarted after an emergency stop, the x-ray and gantry mot | 82 | 2009-12-23 |
| 2008-01-04 | Not classified | Labeling design | Misbranding; These devices do not bear the manufacturer’s name or address. | 71 | 2010-10-22 |
| 2006-07-13 | Not classified | Finished device change control | The hard drive may crash, resulting in loss of data from patient CT scans. | 5 | 2008-03-13 |
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.