Data / Medical devices / Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System (NVV): 12 FDA-registered makers in 8 countries
12 establishments in 8 countries are registered with the FDA to make Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System (product code NVV, Class 1, 21 CFR 862.2100). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- NVV
- Device class
- 1
- Regulation
- 862.2100
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Germany | 2 |
| United Kingdom | 1 |
| China | 1 |
| Japan | 1 |
| Brazil | 1 |
| Italy | 1 |
| Taiwan | 1 |
Makers of Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aspyra, LLC. | Jacksonville, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cirdan Imaging Limited | Lisburn Antrim and Newtownabbey, United Kingdom | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CliniSys, Inc | Tucson, AZ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Equitar Technologies, Inc. | La Jolla, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Euroimmun Medizinische Labordiagnostika AG | Luebeck Schleswig-Holstein, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| EUROIMMUN Medizinische Labordiagnostika AG | Dassow Mecklenburg-Western Pomerania, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hangzhou Diagens Biotechnology Co., Ltd. | Hangzhou Zhejiang, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Inami & Co., Ltd. | Bunkyo Tokyo, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical San Industria De Equipamentos Medicos Ltda | Estrela Rio Grande do Sul, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Milestone S.P.A. | Sorisole Bergamo, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vistapath Biosystems Inc. | Cambridge, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wellgen Medical Co., Ltd | Kaohsiung City, Taiwan | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.