Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
NVV · Class I — Low Risk (general controls) · Clinical Chemistry · 21 CFR 862.2100
Classification
FDA Product Code
NVV
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 862.2100
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.