FDA product code NVV: Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
NVV is the FDA product code for digital image, storage and communications, non-diagnostic, laboratory information system. It is a Class I device, regulated under 21 CFR 862.2100 and reviewed by the Clinical Chemistry panel. Devices under NVV reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Definition
Intended for clinical laboratory image storage and communications. A clinical laboratory image storage and communications device is a device that provides electronic storage and retrieval functions, and provides electronic transfer for non-diagnostic clinical laboratory images. Images are not intended for diagnostic purposes and not intended for radiological images.
Classification
| Field | Value |
|---|---|
| Device name | Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System |
| Device class | Class I |
| Regulation | 21 CFR 862.2100 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Recalls for NVV devices
openFDA lists no recalls for product code NVV.
Frequently asked questions
What is FDA product code NVV?
NVV is the FDA product code for digital image, storage and communications, non-diagnostic, laboratory information system. It is a Class I device, regulated under 21 CFR 862.2100 and reviewed by the Clinical Chemistry panel.
What device class is NVV?
Class I, regulation 21 CFR 862.2100. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code NVV
- Run a recall and safety report across every NVV manufacturer
- Watch product code NVV for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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