510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K961105Substantially Equivalent

Skin Dose Monitor

Mcmahon Medical, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K961105 is the FDA 510(k) clearance record for SKIN DOSE MONITOR, a class II device, cleared for Mcmahon Medical on under FDA product code OWB (Interventional Fluoroscopic X-Ray System). FDA's definition for product code OWB reads: "Interventional fluoroscopy". FDA records list one 510(k) clearance for Mcmahon Medical. As of , FDA records show no recalls naming K961105.

Clearance record

Decision date
Received
(169 days to decision)
Product code
OWB Interventional Fluoroscopic X-Ray System
Regulation
21 CFR 892.1650
Device class
Class II
Review panel
Radiology
Applicant
Mcmahon Medical 9823 Pacific Heights Blvd.,, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code OWB

Trailing 12 months
19 clearances under product code OWB in the twelve months to October 2026, April 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code OWB, trailing twelve months
MonthClearances
November 20251
December 20253
January 20261
February 20262
March 20262
April 20264
May 20261
June 20260
July 20262
August 20263
September 20260
October 20260