Cleared Traditional

K103424 - SAFIRE

K103424 is the FDA 510(k) clearance for SAFIRE by Siemens Medical Solutions USA, Inc.. It is a Class 2 Radiology device (product code JAK) cleared through the Traditional 510(k) pathway after a 365-day FDA review.

K103424 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
365d
Days
Class 2
Risk

K103424 is an FDA 510(k) clearance for the SAFIRE. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Malvern, US). The FDA issued a Cleared decision on November 22, 2011 after a review of 365 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1750 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K103424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2010
Decision Date November 22, 2011
Days to Decision 365 days
Submission Type Traditional
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
258d slower than avg
Panel avg: 107d · This submission: 365d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAK System, X-ray, Tomography, Computed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1750
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 - JAK System, X-ray, Tomography, Computed

All 581
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K103424.
AQUILION CXL
K112989 · Toshiba America Medical Systems, In.C · Apr 2012
AQUILION PRIME
K120710 · Toshibamedical Systems Corporation · Apr 2012
AQUILION PRIME
K110066 · Toshiba America Medical Systems, In.C · Jan 2012
GE VEO RECONSTRUCTION OPTION
K103489 · General Electric Co. · Sep 2011
AQUILION LB MOVEMENT BASE KIT
K111633 · Toshiba America Medical Systems, In.C · Aug 2011
OPTIMA CT660
K110227 · Ge Medical Systems, LLC · Jul 2011