RadSuite
Catalogue number 8.32, listed by Merge Healthcare Solutions Inc., 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
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 | Merge Healthcare Solutions Inc. |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| 510(k) | K053281 |
| Record published | 2019-09-25 |
| Record revised | 2026-05-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2019-12-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8.32 | Withdrawn |
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
Recalls Naming This Product
8 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Merge Healthcare Incorporated | 510(k) number | 2016-07-14 | Class II | Software design | It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of the patient to radiation (x-ray). | 29 | 2018-08-30 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-31 | Class II | Software design | Potential for RadSuite AV viewer to skip image slices when the user presses page up or page down when the viewer displays multiple viewports and the user has mouse focused on any viewport other than the first viewport. | 25 sites potentially have the affected versions | 2017-02-10 |
| Merge Healthcare Incorporated | 510(k) number | 2016-01-30 | Class II | Software design | Interventional Radiology (IR) images are stored as JPEG2k Lossless in Merge Enterprise Archive (EA) and are not displaying correctly in RadSuite. | 96 sites potentially have the affected versions for both pro | 2019-10-15 |
| Merge Healthcare Incorporated | 510(k) number | 2015-12-17 | Class II | Software design | Potential incorrect Standardized Uptake Values (SUV) measurements in RadSuite. | 164 | 2016-05-10 |
| Merge Healthcare Incorporated | 510(k) number | 2015-11-17 | Class II | Software design | The values provided from the Pixel Value tool do not appear to be correct, which may result in potential patient injury or delay in diagnosis or treatment. | 8 sites have the potentially affected version | 2017-02-10 |
| Merge Healthcare Incorporated | 510(k) number | 2015-04-09 | Class II | Software design | When RadSuite is used with IPID (Issuer of Patient ID) as a part of the “Patient Identifier,” it is possible in some circumstances that the demographics of one patient will be applied to a study or studies for another patient. | 10 sites have the affected software that is configured with | 2017-08-24 |
| Merge Healthcare Incorporated | 510(k) number | 2013-05-06 | Class II | Software design | Multiple studies were missing at a customer location that never made it to the archive before watermarking | 45 sites potentially have the affected versions | 2019-07-26 |
| Merge Healthcare Incorporated | 510(k) number | 2008-01-01 | Not classified | Device Design | Miscalculation: The calculation of the standard uptake value does not include the required calibration factor/decay correction factor. The resulting value is incorrectly calculated, which may lead to incorrect interpretation of tissue dens | 99 | 2009-06-11 |
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.