Cleared Traditional

K974597 - ADC COMPACT (AGFA DIAGNOSTIC CENTER)

K974597 is an FDA 510(k) clearance for ADC COMPACT (AGFA DIAGNOSTIC CENTER), manufactured by Bayer Corp., Agfa Div.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974597 · Bayer Corp., Agfa Div. · Radiology device
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Mar 1998
Decision
90d
Days
Class 2
Risk

K974597 is an FDA 510(k) clearance for the ADC COMPACT (AGFA DIAGNOSTIC CENTER). Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Bayer Corp., Agfa Div. (Ridgefield Park, US). The FDA issued a Cleared decision on March 9, 1998 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 892.1680 - 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 Bayer Corp., Agfa Div. devices

FDA 510(k) Submission Details - K974597

510(k) Number K974597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1997
Decision Date March 09, 1998
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
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.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 215
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K974597.
DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K982196 · GE Medical Systems · Oct 1998
PHILIPS THORAVISION
K981657 · Philips Medical Systems North America, Inc. · Jun 1998
VARIAN XIMATRON SCAN VISION CT
K981056 · Varian Medical Systems, Inc. · Jun 1998
VACUDAP, MODEL 2000, 2001
K974112 · Victoreen, Inc. · Jan 1998
DIGITAL ADD ON MULTI SYSTEM
K973710 · Swissray International, Inc. · Dec 1997
DIGITAL ADD-ON BUCKY
K970136 · Swissray Teleray AG · Nov 1997