Epiq 5 Diamond Select Ultrasound System
Catalogue number 795120, listed by Philips Ultrasound LLC, United States, under System, Image Processing, Radiological. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
1catalogue number
13510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (5), Beijing (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shantou Institute OF Ultrasonic Instruments Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Coretronic Projection (Kunshan) Corporation | Kunshan | Jiangsu | Contract manufacturer | 3 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Arthrex (Shanghai) Co., Ltd. | Shanghai | Shanghai | Exporter | 38 |
| GE Hangwei Medical Systems 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 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| Beijing Infervision Healthcare Medical Technology Co., Ltd. | Beijing | Beijing | Complaint-file establishment | 4 |
Showing 12 of 16. All 16 manufacturers in China registered for System, Image Processing, Radiological
Record
| Listed by | Philips Ultrasound LLC, United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2021-09-21 |
| Record revised | 2024-06-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 795120 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Imagegrid Radiology Viewer System | Candelis, Inc. | 173 |
| Tims System | Foresight Imaging, LLC | 159 |
| System, Image Processing, Radiological | Biomet Microfixation | 146 |
| RamSoft | Ramsoft, Inc. | 65 |
| Joints | Medstrat | 62 |
| OrthoView | Meridian Technique Ltd | 54 |
| IPS | KLS-Martin L.P. | 48 |
| NovaPACS | Novarad Corp. | 42 |
| PointCloud Knee Instruments | Unik Orthopedics, Inc | 34 |
| DTX Studio™ Clinic | Nobel Biocare AB | 34 |
| Eaglesoft | Patterson Technology Center | 33 |
| Medtronic Navigation | Medtronic Navigation, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212777 | 2021-09-24 |
| K200603 | 2020-09-20 |
| K201665 | 2020-09-15 |
| K181264 | 2018-06-07 |
| K140808 | 2014-04-17 |
| K132165 | 2013-08-09 |
| K121223 | 2012-05-15 |
| K110414 | 2011-06-21 |
| K103815 | 2011-01-25 |
| K070792 | 2007-04-06 |
| K061396 | 2006-05-30 |
| K040227 | 2004-02-17 |
| K023877 | 2002-12-23 |
Recalls
5 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 |
|---|---|---|---|---|---|
| 2015-05-15 | Class II | Software design | Philips Healthcare has discovered a problem in the Philips Ultrasound Q-Station version 3.0 or higher that could result in measurements from a study (Structured Report) to be appended to subsequent studies for other patients. | 125 units (30 in US and 95 international) | 2016-08-08 |
| 2014-11-05 | Class II | Software design | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV | 43 units (13 in US and 30 outside US) | 2016-08-15 |
| 2014-11-05 | Class II | Software design | When using the QLAB Auto 2D Quantification (a2DQ) and Auto Cardiac Motion Quantification (aCMQ) applications, the reported End-Systolic Volume (ESV) may be smaller, and the Left Ventricular Ejection Fraction (EF) may be higher, than the ESV | additional 52 international units; 261 units (73 in the US a | 2016-08-15 |
| 2014-07-09 | Class II | Software change control | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. | 25 units total (2 units in the US and 23 units outside the U | 2015-11-06 |
| 2014-07-09 | Class II | Software change control | The QLAB a2DQ and aCMQ features have a defect that may use incorrect measurement values under specific conditions. | 59 units total (12 units in the US and 47 units outside the | 2015-11-06 |
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.