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
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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.

View all Anrad Corp. devices

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
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 330
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