510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861233Substantially Equivalent

Dual Photon Bone Densitometer

Medical and Scientific Enterprises, Inc., Concord MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861233 is the FDA 510(k) clearance record for DUAL PHOTON BONE DENSITOMETER, a class II device, cleared for Medical and Scientific Enterprises, Inc. on under FDA product code KGI (Densitometer, Bone). FDA records list 5 510(k) clearances for Medical and Scientific Enterprises, Inc., from to . As of , FDA records show no recalls naming K861233.

Clearance record

Decision date
Received
(336 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Medical and Scientific Enterprises, Inc. P.O. Box 661, Concord MA
Third party review
No

Clearances, product code KGI

Trailing 12 months
2 clearances under product code KGI in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KGI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260