NovaPACS
A picture archiving and communication system software that retrieves, archives, distributes, and displays images and data from all common modalities.
16manufacturers in China registered for this device type
42catalogue numbers in this listing
6510(k) clearances naming this product code
4recalls 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 | Novarad Corp., United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K171754 |
| Record published | 2022-04-18 |
| Record revised | 2024-02-08 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NovaPACS 8.9.1 | In distribution | |
| NovaPACS 8.6.5 | In distribution | |
| NovaPACS 8.5.17 | In distribution | |
| NovaPACS 8.5.12 | In distribution | |
| NovaPACS 8.5.8 | In distribution | |
| NovaPACS 8.8.5 | In distribution | |
| NovaPACS 8.5.9 | In distribution | |
| NovaPACS 8.6.7 | In distribution | |
| NovaPACS 9.1.3 | In distribution | |
| NovaPACS 9.1.4 | In distribution | |
| NovaPACS 8.6.3 | In distribution | |
| NovaPACS 8.9.3 | In distribution | |
| NovaPACS 8.7.4 | In distribution | |
| NovaPACS 8.5.18 | In distribution | |
| NovaPACS 8.6.4 | In distribution | |
| NovaPACS 8.10.7 | In distribution | |
| NovaPACS 8.7.6 | In distribution | |
| NovaPACS 8.6.6 | In distribution | |
| NovaPACS 8.9.2 | In distribution | |
| NovaPACS 8.7.8 | In distribution | |
| NovaPACS 8.10.5 | In distribution | |
| NovaPACS 8.6.9 | In distribution | |
| NovaPACS 8.5.14 | In distribution | |
| NovaPACS 8.6.11 | In distribution | |
| NovaPACS 8.8.4 | In distribution | |
| NovaPACS 8.6.8 | In distribution | |
| NovaPACS 8.8.3 | In distribution | |
| NovaPACS 8.5.19 | In distribution | |
| NovaPACS 8.5.15 | In distribution | |
| NovaPACS 8.6.14 | In distribution | |
| NovaPACS 8.5.6 | In distribution | |
| NovaPACS 9.1.5 | In distribution | |
| NovaPACS 8.7.7 | In distribution | |
| NovaPACS 8.6.12 | In distribution | |
| NovaPACS 8.10.3 | In distribution | |
| NovaPACS 8.5.16 | In distribution | |
| NovaPACS 8.5.10 | In distribution | |
| NovaPACS 8.5.7 | In distribution | |
| NovaPACS 8.5.11 | In distribution | |
| NovaPACS 9.1.6 | In distribution | |
| NovaPACS 8.7.11 | In distribution | |
| NovaPACS 8.6.1 | 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 |
| 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 |
| VSP System | 3D Systems, Inc. | 26 |
Showing 12 of 1,109. All products under System, Image Processing, Radiological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172418 | 2018-09-21 |
| K171754 | 2017-07-28 |
| K160371 | 2016-10-14 |
| K132853 | 2014-10-30 |
| K063153 | 2006-12-07 |
| K061920 | 2006-08-21 |
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 |
|---|---|---|---|---|---|---|---|
| Novarad Corp. | 510(k) number | 2019-09-10 | Class II | Software Design Change | The firm received a report of an atypical dataset being generated. When using the cross-localization feature and images from a modality that generates asymmetrical images, the cross-localization reference line may be inaccurately placed on | 197 units | 2021-06-30 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2016-08-12 | Class II | Software design | Novarad Corporation announces a voluntary field action for the NovaPACS versions 8.4.7, 8.5.3, and 8.5.6 due to a “pop-up screen” that was prematurely released. | 90 | 2017-02-22 |
| 2015-11-16 | Class II | Software design | The SUV values that are being calculated in the PET/CT fusion tool are incorrect. | 2,386 | 2016-08-17 |
| 2013-05-09 | Class II | Software design | Potential for images to be flipped while streaming, which could incorrectly display image orientation markers. | 2695 | 2016-12-01 |
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.