Cleared Traditional

SYNGO INSPACE 4D (K043469) - FDA 510(k) Clearance

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

K043469 · Siemens AG Medical Solutions · Radiology device
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Feb 2005
Decision
49d
Days
Class 2
Risk

K043469 is an FDA 510(k) clearance for the SYNGO INSPACE 4D. Classified as System, X-ray, Tomography, Computed (product code JAK), Class II - Special Controls.

Submitted by Siemens AG Medical Solutions (Forchheim, Bavaria, DE). The FDA issued a Cleared decision on February 3, 2005 after a review of 49 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 AG Medical Solutions devices

Submission Details

510(k) Number K043469 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2004
Decision Date February 03, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 107d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 352
Devices cleared under the same product code (JAK) and FDA review panel - the closest regulatory comparables to K043469.
SOMATOM DEFINITION, MODEL AS/AS+
K081022 · Siemens Medical Solutions USA, Inc. · Jun 2008
SYNGO DUAL ENERGY
K062351 · Siemens Medical Solutions USA, Inc. · Oct 2006
BRILLIANCE VOLUME
K060937 · Philips Medical Systems (Cleveland), Inc. · Jun 2006
SOMATOM RESPIRATORY GATING
K043086 · Siemens Medical Solutions USA, Inc. · Dec 2004
SOMATOM CARE CONTRAST CT
K043087 · Siemens Medical Solutions USA, Inc. · Dec 2004
BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER
K042293 · Philips Medical Systems (Cleveland), Inc. · Sep 2004