Cleared Traditional

K972130 - DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR

K972130 is an FDA 510(k) clearance for DISPOSABLE CAMERA COVER, manufactured by Fairmontmedical. The device is a Class 2 Radiology device with product code IZJ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K972130 · Fairmontmedical · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
125d
Days
Class 2
Risk

K972130 is an FDA 510(k) clearance for the DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPO.... Classified as Camera, X-ray, Fluorographic, Cine Or Spot (product code IZJ), Class II - Special Controls.

Submitted by Fairmontmedical (Bayswater, Victoria, AU). The FDA issued a Cleared decision on October 9, 1997 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1620 - 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.

View all Fairmontmedical devices

FDA 510(k) Submission Details - K972130

510(k) Number K972130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1997
Decision Date October 09, 1997
Days to Decision 125 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
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IZJ Device Classification - Class 2, Special Controls

Product Code IZJ Camera, X-ray, Fluorographic, Cine Or Spot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1620
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 - IZJ Camera, X-ray, Fluorographic, Cine Or Spot

Devices cleared under the same product code (IZJ) and FDA review panel - the closest regulatory comparables to K972130.
DSP OPTION
K945580 · Philips Medical Systems (Cleveland), Inc. · Jan 1995
PHILIPS DSI SYSTEM RELEASE 3.2
K920793 · Philips Medical Systems, Inc. · Jul 1992
DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688 · Adac Laboratories · May 1988
CANON X-RAY 35MM CINE CAMERA CSI-35
K853983 · Canon USA, Inc. · Oct 1985
SIRCAM 103
K810191 · Siemens Corp. · Feb 1981
SIRCAM 106
K792394 · Siemens Corp. · Dec 1979