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NVV — Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System Class I

FDA Device Classification

FDA product code NVV covers "Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System", a Class I medical device regulated under 21 CFR 862.2100. Submissions are reviewed by the Clinical Chemistry panel.

Classification Details

Product Code
NVV
Device Class
Class I
Regulation Number
862.2100
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

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.

FDA data resources