Cleared Abbreviated

K040995 - SYNERAD MULTI DIGITAL X-RAY SYSTEM

K040995 is the FDA 510(k) clearance for SYNERAD MULTI DIGITAL X-RAY SYSTEM by Analogic Corp.. It is a Class 2 Radiology device (product code KPR) cleared through the Abbreviated 510(k) pathway after a 39-day FDA review.

K040995 · Analogic Corp. · Radiology device
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Optimized for regulatory review, auditing and printing
May 2004
Decision
39d
Days
Class 2
Risk

K040995 is an FDA 510(k) clearance for the SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Analogic Corp. (Peabody, US). The FDA issued a Cleared decision on May 25, 2004 after a review of 39 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 Corp. devices

Submission Details

510(k) Number K040995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2004
Decision Date May 25, 2004
Days to Decision 39 days
Submission Type Abbreviated
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
68d faster than avg
Panel avg: 107d · This submission: 39d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code KPR System, X-ray, Stationary
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 - KPR System, X-ray, Stationary

All 171
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K040995.
MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING
K050704 · General Electric Co. · Apr 2005
MULTIDIAGNOST ELEVA
K050151 · Philips Medical Systems North America, Inc. · Feb 2005
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025 · Analogic Corp. · Nov 2004
AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS
K033345 · Analogic Corp. · Nov 2003
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM
K012389 · Ge Medical Systems, Inc. · Aug 2001