Cleared Traditional

K965004 - C.A.R.E. VISION FOR THE SOMATOM PLUS 4 ...

K965004 is the FDA 510(k) clearance for C.A.R.E. VISION FOR THE SOMATOM PLUS 4 ... 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 85-day FDA review.

K965004 · Siemens Medical Solutions USA, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 1997
Decision
85d
Days
Class 2
Risk

K965004 is an FDA 510(k) clearance for the C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on March 11, 1997 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Siemens Medical Solutions USA, Inc. devices

Submission Details

510(k) Number K965004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1996
Decision Date March 11, 1997
Days to Decision 85 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
22d faster than avg
Panel avg: 107d · This submission: 85d
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 K965004.
OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS
K971054 · Siemens Medical Solutions USA, Inc. · Jun 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · Elscint, Inc. · May 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · GE Medical Systems · Apr 1997
SOMATOM PLUS 4 CT SCANNER
K964747 · Siemens Medical Solutions USA, Inc. · Feb 1997
HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION
K964746 · GE Medical Systems · Jan 1997
XRT-7.0
K964583 · Elscint, Inc. · Jan 1997