Cleared Special

K071015 - OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM

K071015 is the FDA 510(k) clearance for OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code IZL) cleared through the Special 510(k) pathway after a 30-day FDA review.

K071015 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 2007
Decision
30d
Days
Class 2
Risk

K071015 is an FDA 510(k) clearance for the OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on May 10, 2007 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1720 - 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 Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K071015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2007
Decision Date May 10, 2007
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.

Device Classification

Product Code IZL System, X-ray, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1720
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 - IZL System, X-ray, Mobile

All 116
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K071015.
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION
K080701 · Shimadzu Corp. · May 2008
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OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM
K072392 · Siemens Medical Solutions USA, Inc. · Sep 2007
GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR
K041922 · General Electric Co. · Jul 2004
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K022337 · Siemens Medical Solutions USA, Inc. · Aug 2002