Ultrasonic Body Composition Analyzer
The Ultrasonic Body Composition Analyzer (product code OMV) is a Class 2 cardiovascular device regulated under 21 CFR 870.2770, cleared via 510(k) and reviewed by the Gastroenterology and Urology panel. It is intended to measure the thickness of distinctive tissue layers such as fat, muscle, and bone at single or multiple body locations, and via algorithms estimate the amount of local or total body tissue for body composition assessment. The device is eligible for third-party review and is not an implant or life-sustaining device.
Research product code OMV in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- OMV
- Device Class
- FDA class 2
- Regulation Number
- 870.2770
- Medical Specialty
- Cardiovascular
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Intended to measure thickness of a distinctive tissue layer. Indicated to Calculate the local thickness of a type of tissue [fat, muscle, bone, etc.] at a single location, or at various locations on the body and via algorithms, estimate the amount of local tissue or total body tissue, respectively.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K082147 | BODYMETRIX BX2000 | Mar 20, 2009 | Substantially Equivalent | Intelametrix, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.