Unifi Workspace
Unifi Workspace is software for viewing and processing mammography, breast tomosynthesis and other DICOM medical images. It supports reference review and diagnostic interpretation by…
Unifi Workspace is software for viewing and processing mammography, breast tomosynthesis and other DICOM medical images. It supports reference review and diagnostic interpretation by trained medical professionals.
The application receives, displays, manipulates, measures, prints and archives images and associated data. It can store and communicate the information locally or across connected computer systems.
Listed Item
Unifi® Software is a software application that is intended for use in receiving, processing, manipulating, displaying, printing, and archiving mammmography images as well as other medical images and data.
Diagnostic Display
Image-processing and measurement tools support interpretation of breast X-ray images and other modalities such as ultrasound or MRI. Primary mammography interpretation requires an appropriately specified diagnostic monitor and images suitable for that purpose. Lossy-compressed mammograms are not intended for primary interpretation.
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 | Hologic, Inc., United States |
|---|---|
| FDA product code | LLZ |
| Device type | System, Image Processing, Radiological |
| Device class | Class 2 |
| Regulation | 21 CFR 892.2050 |
| Establishment | Remanufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K190694 |
| Record published | 2019-08-09 |
| Record revised | 2024-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2020-09-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Unifi Workspace V1.0 | Withdrawn | |
| Unifi Workspace V1.0 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K190694 | 2019-07-11 |
| K163623 | 2017-10-20 |
| K142037 | 2014-10-10 |
| K140960 | 2014-06-13 |
| K132316 | 2013-10-30 |
| K123530 | 2012-12-20 |
| K120472 | 2012-06-22 |
| K103385 | 2011-02-02 |
| K091368 | 2009-06-04 |
| K082483 | 2008-09-12 |
| K062107 | 2006-08-18 |
| K041555 | 2004-08-09 |
| K032546 | 2003-10-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-02-28 | Not classified | Software design | SecurView DX with software version 7.3.0 defects when used to view mammography tomosynthesis images | 7 units | 2012-05-07 |
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.