Cleared Traditional

K043087 - SOMATOM CARE CONTRAST CT

K043087 is an FDA 510(k) clearance for SOMATOM CARE CONTRAST CT, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code JAK cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K043087 · Siemens Medical Solutions USA, Inc. · Radiology device
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Dec 2004
Decision
37d
Days
Class 2
Risk

K043087 is an FDA 510(k) clearance for the SOMATOM CARE CONTRAST CT. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on December 15, 2004 after a review of 37 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

FDA 510(k) Submission Details - K043087

510(k) Number K043087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date December 15, 2004
Days to Decision 37 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
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JAK Device Classification - Class 2, Special Controls

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 724
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K043087.
SOMATOM EMOTION 16
K050297 · Siemens Medical Solution, Inc. USA · Mar 2005
SYNGO INSPACE 4D
K043469 · Siemens AG Medical Solutions · Feb 2005
SOMATOM RESPIRATORY GATING
K043086 · Siemens Medical Solutions USA, Inc. · Dec 2004
PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A
K043111 · Toshiba America Medical Systems, In.C · Nov 2004
SUPERDIMENSION/BRONCHUS
K042438 · Superdimension, Ltd. · Nov 2004
SOMATOM SPIRIT
K042328 · Siemens Medical Systems, Inc. · Sep 2004