510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K113616Substantially Equivalent

Accudxa2

Lone Oak Medical Technologies, LLC, Doylestown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113616 is the FDA 510(k) clearance record for ACCUDXA2, a class II device, cleared for Lone Oak Medical Technologies, LLC on under FDA product code KGI (Densitometer, Bone). FDA records list one 510(k) clearance for Lone Oak Medical Technologies, LLC. As of , FDA records show no recalls naming K113616.

Clearance record

Decision date
Received
(142 days to decision)
Product code
KGI Densitometer, Bone
Regulation
21 CFR 892.1170
Device class
Class II
Review panel
Radiology
Applicant
Lone Oak Medical Technologies, LLC 3805 Old Easton Rd., Doylestown PA
510(k) summary
Summary PDF
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