Cleared Traditional

K042791 - INSTANT-X, MODELS 1713 & 128

K042791 is an FDA 510(k) clearance for INSTANT-X, manufactured by Ann Arbor Digital Devices. The device is a Class 2 Radiology device with product code MQB cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K042791 · Ann Arbor Digital Devices · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Ann Arbor Digital Devices devices

FDA 510(k) Submission Details - K042791

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.

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 332
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K042791.
DIGITAL RADIOGRAPHY CXDI-50C
K060433 · Canon, Inc. · Mar 2006
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
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · Konica Minolta Medical & Graphic, Inc. · Jul 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925 · Shimadzu Corp. · Jun 2005