Cleared Special

K052136 - GR17 DIGITAL DETECTOR

K052136 is an FDA 510(k) clearance for GR17 DIGITAL DETECTOR, manufactured by Anrad Corp.. The device is a Class 2 Radiology device with product code MQB cleared through the Special 510(k) pathway after a 20-day FDA review.

K052136 · Anrad Corp. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
20d
Days
Class 2
Risk

K052136 is an FDA 510(k) clearance for the GR17 DIGITAL DETECTOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Anrad Corp. (Peabody, US). The FDA issued a Cleared decision on August 25, 2005 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 - K052136

510(k) Number K052136 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2005
Decision Date August 25, 2005
Days to Decision 20 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
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MQB Device Classification - Class 2, Special Controls

Product Code MQB Solid State X-ray Imager (flat Panel/digital Imager)
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 - MQB Solid State X-ray Imager (flat Panel/digital Imager)

All 423
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K052136.
REGIUS MODEL 170 DIRECT DIGITIZER
K051998 · Konica Minolta Medical & Graphic, Inc. · Nov 2005
MODIFICATION TO: DIRECT DIGITIZER REGIUS MODEL 190
K052095 · Konica Minolta Medical & Graphic, Inc. · Nov 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K051494 · Cr Tech, Ltd. · Sep 2005
INSTANT-X, MODELS 1713 & 128
K042791 · Ann Arbor Digital Devices · Jul 2005
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · Konica Minolta Medical & Graphic, Inc. · Jul 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005
K052136 · GR17 DIGITAL DETECTOR
Download PDF FDA Summary Anrad Corp.