510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K864299Substantially Equivalent

Novo Bmc-Lab 23, Bone Densitometer

Scan Detectronic Laboratories, Inc., New Milford CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864299 is the FDA 510(k) clearance record for NOVO BMC-LAB 23, BONE DENSITOMETER, a class II device, cleared for Scan Detectronic Laboratories, Inc. on under FDA product code KGI (Densitometer, Bone). FDA records list one 510(k) clearance for Scan Detectronic Laboratories, Inc. As of , FDA records show no recalls naming K864299.

Clearance record

Decision date
Received
(377 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Scan Detectronic Laboratories, Inc. 512 Danbury Rd., New Milford CT
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