510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K082147Substantially Equivalent

Bodymetrix Bx2000

Intelametrix, Inc., Livermore CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082147 is the FDA 510(k) clearance record for BODYMETRIX BX2000, a class II device, cleared for Intelametrix, Inc. on under FDA product code OMV (Ultrasonic Body Composition Analyzer). FDA's definition for product code OMV reads: "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...". FDA records list one 510(k) clearance for Intelametrix, Inc. As of , FDA records show no recalls naming K082147.

Clearance record

Decision date
Received
(233 days to decision)
Product code
OMV Ultrasonic Body Composition Analyzer
Regulation
21 CFR 870.2770
Device class
Class II
Review panel
Cardiovascular
Applicant
Intelametrix, Inc. 6246 Preston Ave., Livermore CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OMV

Trailing 12 months

FDA records hold no clearances under product code OMV in the trailing twelve months.

FDA records show no clearances under product code OMV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OMV, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260