Cleared Traditional

K024085 - CCD CAMERA, MODEL PKP-06000-000

K024085 is an FDA 510(k) clearance for CCD CAMERA, manufactured by Perkins Electronics Co.. The device is a Class 2 Radiology device with product code IZJ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K024085 · Perkins Electronics Co. · Radiology device
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Mar 2003
Decision
90d
Days
Class 2
Risk

K024085 is an FDA 510(k) clearance for the CCD CAMERA, MODEL PKP-06000-000. Classified as Camera, X-ray, Fluorographic, Cine Or Spot (product code IZJ), Class II - Special Controls.

Submitted by Perkins Electronics Co. (Dallas, US). The FDA issued a Cleared decision on March 11, 2003 after a review of 90 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 Perkins Electronics Co. devices

FDA 510(k) Submission Details - K024085

510(k) Number K024085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2002
Decision Date March 11, 2003
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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

All 7
Devices cleared under the same product code (IZJ) and FDA review panel - the closest regulatory comparables to K024085.
DISPOSABLE CAMERA COVER, ENCLOSED: DISPOSABLE CAMERA COVER, PERFORATED: DISPOSABLE MICROSCOPE COVER (VARIOUS):X-RAY COVR
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DSP OPTION
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DTV-4114 FLUOROSCOPIC TELEVISION CAMERA
K881688 · Adac Laboratories · May 1988
CANON X-RAY 35MM CINE CAMERA CSI-35
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SIRCAM 103
K810191 · Siemens Corp. · Feb 1981