Cleared Traditional

K042791 - INSTANT-X, MODELS 1713 & 128 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042791 · Ann Arbor Digital Devices · Radiology device
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Jul 2005
Decision
267d
Days
Class 2
Risk

K042791 is an FDA 510(k) clearance for the INSTANT-X, MODELS 1713 & 128. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Ann Arbor Digital Devices (Ann Arbor, US). The FDA issued a Cleared decision on July 1, 2005 after a review of 267 days - an extended review cycle.

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.

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Submission Details

510(k) Number K042791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2004
Decision Date July 01, 2005
Days to Decision 267 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 107d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 420
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