Cleared Special

K033345 - AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS

K033345 is an FDA 510(k) clearance for AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS, manufactured by Analogic Corp.. The device is a Class 2 Radiology device with product code KPR cleared through the Special 510(k) pathway after a 30-day FDA review.

K033345 · Analogic Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
30d
Days
Class 2
Risk

K033345 is an FDA 510(k) clearance for the AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS. 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 November 19, 2003 after a review of 30 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 Analogic Corp. devices

FDA 510(k) Submission Details - K033345

510(k) Number K033345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2003
Decision Date November 19, 2003
Days to Decision 30 days
Submission Type Special
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
77d faster than avg
Panel avg: 107d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

KPR Device Classification - Class 2, Special Controls

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 275
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K033345.
SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250
K043025 · Analogic Corp. · Nov 2004
URS LP DIGITAL, MILLENNIUM, RADPRO
K042876 · Sedecal., Sa. · Nov 2004
SYNERAD MULTI DIGITAL X-RAY SYSTEM, MODEL AN6150
K040995 · Analogic Corp. · May 2004
PHILIPS EASYDIAGNOST ELEVA
K031535 · Philips Medical Systems North America Co. · Jun 2003
AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTEM)
K013826 · Siemens Medical Systems, Inc. · Feb 2002
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION
K013481 · GE Medical Systems · Nov 2001