Cleared Traditional

SOMATOM PROJECT 059 (K941546) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K941546 · Siemens Corp. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
173d
Days
Class 2
Risk

K941546 is an FDA 510(k) clearance for the SOMATOM PROJECT 059. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Corp. (Iselin, US). The FDA issued a Cleared decision on September 20, 1994 after a review of 173 days - an extended review cycle.

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. Standard predicate reliance. 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 Corp. devices

Submission Details

510(k) Number K941546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1994
Decision Date September 20, 1994
Days to Decision 173 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 107d · This submission: 173d
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 421
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K941546.
PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM
K955268 · Philips Medical Systems (Cleveland), Inc. · Jan 1996
PQ5000 CT SYSTEM
K943623 · Philips Medical Systems (Cleveland), Inc. · Apr 1995
CT PROSPEED FAMILY
K944013 · GE Medical Systems · Feb 1995
HISPEED ADVANTAGE II
K940606 · GE Medical Systems · Aug 1994
TSX-002A (XVISION) CT SCANNER
K941745 · Toshiba America Medical Systems, In.C · Jul 1994
VOLUMETRIC RENDERING TECHNIQUE OPTION
K923524 · Siemens Medical Solutions USA, Inc. · May 1994