Cleared Special

K000159 - AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO

K000159 is an FDA 510(k) clearance for AGFA DIAGNOSTIC CENTER ADC, manufactured by Agfa Corp.. The device is a Class 2 Radiology device with product code IXK cleared through the Special 510(k) pathway after a 28-day FDA review.

K000159 · Agfa Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
28d
Days
Class 2
Risk

K000159 is an FDA 510(k) clearance for the AGFA DIAGNOSTIC CENTER ADC, ADC COMPACT, AND ADC SOLO. Classified as System, Imaging, X-ray, Electrostatic (product code IXK), Class II - Special Controls.

Submitted by Agfa Corp. (Greenville, US). The FDA issued a Cleared decision on February 16, 2000 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1630 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000159

510(k) Number K000159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2000
Decision Date February 16, 2000
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

IXK Device Classification - Class 2, Special Controls

Product Code IXK System, Imaging, X-ray, Electrostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1630
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 - IXK System, Imaging, X-ray, Electrostatic

All 11
Devices cleared under the same product code (IXK) and FDA review panel - the closest regulatory comparables to K000159.
RADIOTHERAPY SOLUTION BASED ON CR
K042779 · Agfa Corp. · Oct 2004
PORT CASSETTE
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K003689 · Canon USA, Inc. · Jan 2002
FUJI FCR IMAGE PROCESSING UNIT IP-U515
K942561 · Fujifilm Medical System U.S.A., Inc. · Dec 1994
DIGORA
K934949 · Orion Corporation Soredex · Feb 1994
FUJI COMPUTED RADIOGRAP HI-C654 DMS CRT IMAGE CONS
K931002 · Fujifilm Medical System U.S.A., Inc. · Jun 1993