Cleared Abbreviated

K032280 - SIREMOBIL ISO-C 3D

K032280 is an FDA 510(k) clearance for SIREMOBIL ISO-C 3D, manufactured by Siemens AG. The device is a Class 2 Radiology device with product code IZL cleared through the Abbreviated 510(k) pathway after a 48-day FDA review.

K032280 · Siemens AG · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
48d
Days
Class 2
Risk

K032280 is an FDA 510(k) clearance for the SIREMOBIL ISO-C 3D. Classified as System, X-ray, Mobile (product code IZL), Class II - Special Controls.

Submitted by Siemens AG (Mavern, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 48 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. 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 Siemens AG devices

FDA 510(k) Submission Details - K032280

510(k) Number K032280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2003
Decision Date September 10, 2003
Days to Decision 48 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
59d faster than avg
Panel avg: 107d · This submission: 48d
Pathway characteristics
Standards-based clearance path.

IZL Device Classification - Class 2, Special Controls

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 142
Devices cleared under the same product code (IZL) and FDA review panel - the closest regulatory comparables to K032280.
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · Shimadzu Corp. · Jul 2004
MINXRAY, MODEL HF120/60H POWERPLUS
K040046 · Minxray, Inc. · Feb 2004
MOBILETTE XP AND MOBILETT XPHYBRID
K033238 · Siemens Medical Systems, Inc. · Nov 2003
3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D
K022337 · Siemens Medical Solutions USA, Inc. · Aug 2002
AMX-4 PLUS MOBILE X-RAY SYSTEM
K021016 · GE Medical Systems · Jun 2002
PORTABLE X-RAY UNITS
K020436 · Sedecal., Sa. · Feb 2002