Digital Image, Storage And Communications, Non-Diagnostic, Laboratory Information System
The Non-Diagnostic Digital Image Storage and Communications Laboratory Information System is a clinical laboratory device providing electronic storage, retrieval, and transfer functions for non-diagnostic laboratory images, excluding radiological images. It is intended to support laboratory workflow and image management without being used for direct diagnostic interpretation. It is an FDA Class 1 device regulated under 21 CFR 862.2100 in the Clinical Chemistry specialty, with product code NVV, and is exempt from premarket notification under submission type 4. It does not carry implant or life-sustaining support designations.
Basic Information
- Product Code
- NVV
- Device Class
- FDA class 1
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.