Cleared Traditional

K961105 - SKIN DOSE MONITOR

K961105 is an FDA 510(k) clearance for SKIN DOSE MONITOR, manufactured by Mcmahon Medical. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K961105 · Mcmahon Medical · Radiology device
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Sep 1996
Decision
169d
Days
Class 2
Risk

K961105 is an FDA 510(k) clearance for the SKIN DOSE MONITOR. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Mcmahon Medical (San Diego, US). The FDA issued a Cleared decision on September 5, 1996 after a review of 169 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K961105

510(k) Number K961105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date September 05, 1996
Days to Decision 169 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 107d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 293
Devices cleared under the same product code (OWB) and FDA review panel - the closest regulatory comparables to K961105.
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K970734 · Siemens Medical Solutions USA, Inc. · Apr 1997
SERIES 7600 MOBILE DIGITAL C-ARM
K970063 · Ge Dec Medical Systems · Mar 1997
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
K963952 · Ge Dec Medical Systems · Dec 1996
PHILIPS MULTIDIAGNOST 4
K961374 · Philips Medical Systems, Inc. · Aug 1996
CLINIX MP
K960920 · Philips Medical Systems (Cleveland), Inc. · May 1996
PHILIPS DCI-SX
K921219 · Philips Medical Systems, Inc. · Apr 1994