Cleared Traditional

K883580 - UNIVERSAL ABC CONTROLER

K883580 is the FDA 510(k) clearance for UNIVERSAL ABC CONTROLER by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code JAA) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K883580 · Philips Medical Systems (Cleveland), Inc. · Radiology device
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Jan 1989
Decision
140d
Days
Class 2
Risk

K883580 is an FDA 510(k) clearance for the UNIVERSAL ABC CONTROLER. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on January 9, 1989 after a review of 140 days - within the typical 510(k) review window.

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.

View all Philips Medical Systems (Cleveland), Inc. devices

Submission Details

510(k) Number K883580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1988
Decision Date January 09, 1989
Days to Decision 140 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 107d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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 - JAA System, X-ray, Fluoroscopic, Image-intensified

All 132
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K883580.
MOBILE X-RAY TELEVISION UNIT WHA-10A/B
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DA-100HS
K894913 · Fischer Imaging Corp. · Sep 1989
DIGITAL SPOT IMAGING (DSI)
K893131 · Philips Medical Systems, Inc. · Jun 1989
MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM
K884317 · Medrad, Inc. · Dec 1988
CARDIAC CX
K883985 · Fischer Imaging Corp. · Nov 1988
CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM
K880527 · Fischer Imaging Corp. · Feb 1988