510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NVVClass I

Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System

21 CFR 862.2100 / Clinical Chemistry
FDA source (opens on fda.gov)

NVV is the FDA product code for Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System, a class I device type, regulated under 21 CFR 862.2100. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NVV
Device name
Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
FDA 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.
Regulation
21 CFR 862.2100
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order