510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K810159Substantially Equivalent

Bone Mineral Analyzer Controller

Lunar Radiation Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K810159 is the FDA 510(k) clearance record for BONE MINERAL ANALYZER CONTROLLER, a class II device, cleared for Lunar Radiation Corp. on under FDA product code KGI (Densitometer, Bone). FDA records list 6 510(k) clearances for Lunar Radiation Corp., from to . As of , FDA records show no recalls naming K810159.

Clearance record

Decision date
Received
(22 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Lunar Radiation Corp. 803 N. Front St. Suite 3, Mchenry IL
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