Cleared Abbreviated

SYNEPIX 4600 DETECTOR (K070829) - FDA 510(k) Clearance

Class II Radiology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K070829 · Analogic Corporation · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
44d
Days
Class 2
Risk

K070829 is an FDA 510(k) clearance for the SYNEPIX 4600 DETECTOR. Classified as Solid State X-ray Imager (flat Panel/digital Imager) (product code MQB), Class II - Special Controls.

Submitted by Analogic Corporation (Peabody, US). The FDA issued a Cleared decision on May 9, 2007 after a review of 44 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. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Analogic Corporation devices

Submission Details

510(k) Number K070829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 09, 2007
Days to Decision 44 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Standards-based clearance path.

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 150
Devices cleared under the same product code (MQB) and FDA review panel - the closest regulatory comparables to K070829.
DRAD3000E/RADREX-I
K082494 · Toshiba America Medical Systems, In.C · Sep 2008
INFX-8000F (INFINIX CSI AND INFINIX DPI)
K081624 · Toshiba America Medical Systems, In.C · Jun 2008
DRAD-3000E, RADREX-I
K073165 · Toshiba America Medical Systems, In.C · Nov 2007
AXIOM ARISTOS FX PLUS
K061054 · Siemens Medical Solutions USA, Inc. · May 2006
KODAK ECLIPSE IMAGE PROCESSING SOFTWARE
K060137 · Eastman Kodak Company · Mar 2006
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · Eastman Kodak Company · Jun 2005