ProxiDiagnost N90
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation…
The ProxiDiagnost N90 is a multi-functional general Radiography/ Fluoroscopy (R/F) system and includes • Footrest • Hand Grips Radiation Protection Accessories • Flexible Radiation Protection Apron • Front Radiation Protection Apron Additional Accessories (Optional) • Monitor Trolley • Monitor Ceiling Suspension • Parking Frame for Accessories • Shoulder Support • Side bar • Compression Belt • Adjustable Lateral Cassette Holder • Leg Supports • Infusion Bottle Holder • Arm Support for Catheterization • Ankle Clamps • Overhead Hand Grip • Adult Headrest • Mattress • Rotatable Stool for Footrest • Pediatric Micturition Set • Stretch Grip for Wall Stand • Bar Code Scanner • Patient Support • Stitching Ruler Accessories for the SkyPlate Detector (Optional) • Mobile Detector Holder • Detector Holder Patient Bed • Portable Panel Protector • Detector Handle • WPD Bags • Grids for SkyPlate Detector large
Who Else Makes It
Concentrated in Beijing (2), Guangdong (2), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Ming FAI Enterprise International Co., Ltd. | Kowloon | Hong Kong | Exporter | 18 |
| Ming FAI Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Shanghai United Imaging Healthcare Co., Ltd. | Shanghai | Shanghai | Manufacturer | 12 |
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Siemens Shenzhen Magnetic Resonance Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Careray Digital Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | Philips Medical Systems DMC GmbH, Germany |
|---|---|
| FDA product code | JAA |
| Device type | System, X-Ray, Fluoroscopic, Image-Intensified |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1650 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2018-05-09 |
| Record revised | 2025-06-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 70 to 110 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 706100 | In distribution | |
| 706110 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Preferred Medical Products, LLC | Preferred Medical Products, LLC | 324 |
| Unbranded | Advance Medical Designs, Inc. | 301 |
| N23 CCD System | Nical SPA | 57 |
| N33 CCD System | Nical SPA | 36 |
| Trinias | Shimadzu Corp. | 31 |
| Custom Cover | Advance Medical Designs, Inc. | 15 |
| Pulse | Nuvasive, Inc. | 15 |
| Sonialvision G4 | Shimadzu Corp. | 13 |
| LessRay | Nuvasive, Inc. | 13 |
| Micro Kover | Advance Medical Designs, Inc. | 11 |
| Stephanix | Stephanix | 10 |
| Snap Kover | Advance Medical Designs, Inc. | 9 |
Showing 12 of 169. All products under System, X-Ray, Fluoroscopic, Image-Intensified
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233945 | 2024-01-11 |
| K232910 | 2023-10-19 |
| K212837 | 2021-09-21 |
| K203087 | 2020-12-03 |
| K163210 | 2017-01-31 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Philips Medical Systems DMC GmbH | UDI-DI | 2025-10-01 | Class II | Device Design | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potenti | 41 units |
| Philips North America LLC | UDI-DI | 2023-12-15 | Class II | Software design | Issue 1: Mixed Images: The Radio Fluoroscopy (RF) viewer may also display a previous patient s radiography (RAD) images when starting the next patient scan while the previous patient image export is still processing. If the issue occurs, th | 151 units; 138 units US; 13 units OUS |
| Philips North America LLC | UDI-DI | 2023-09-21 | Class II | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. | 101 units |
| Philips North America LLC | UDI-DI | 2022-10-21 | Class II | Component design/selection | Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic sleeve which can crack and damage the cable. If the tabletop cable breaks, the user | Total Quantity: 234 units. US 195units. R.O.W 39 units |
| Philips North America LLC | UDI-DI | 2021-10-21 | Class II | Device Design | If the system experiences an overvoltage / power surge it can cause a short circuit condition within the Main- cabinet. If this issue occurs, the user may experience an electrical fire within the cabinet, see or smell smoke emitting from th | 243 units |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2025-10-01 | Class II | Device Design | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potenti | 42 units | |
| 2025-10-01 | Class II | Device Design | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to potenti | 17 units | |
| 2021-05-19 | Class II | Radiation Control for Health and Safety Act | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the Wallst | 140 systems in total, (Updated 1/30/2023). | |
| 2020-07-22 | Class II | Radiation Control for Health and Safety Act | Philips has become aware of a software issue, where the kV and mA values are not locked immediately but change when the collimator shutter position is changed directly after the Lock-In command. This software issue leads to an over or under | 322 systems; 66 in US | |
| 2019-12-19 | Class II | Software design | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the un | 116 | 2020-06-18 |
| 2019-12-19 | Class II | Software design | When using the Table Up/Down button, the system may experience Error 80, which locks the geometry in that specific state, requiring the intervention of a service Engineer. Additionally, the thermos switch, which handles power down of the un | 131 | 2020-06-18 |
| 2018-11-07 | Class II | Software design (manufacturing process) | kV/mA lockin not functioning as specified which may result in the patient receiving an increased radiation dose. | 146 | 2020-09-02 |
| 2012-03-09 | Not classified | Software design | Underexposed image due to lag in switching between auxiliaries | 88 units | 2013-05-23 |
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.