Cleared Special

K071068 - BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197

K071068 is an FDA 510(k) clearance for BIOGRAPH 6 TRUEPOINT, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Special 510(k) pathway after a 28-day FDA review.

K071068 · Siemens Medical Solutions USA, Inc. · Radiology device
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May 2007
Decision
28d
Days
Class 2
Risk

K071068 is an FDA 510(k) clearance for the BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Knoxville, US). The FDA issued a Cleared decision on May 14, 2007 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K071068

510(k) Number K071068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2007
Decision Date May 14, 2007
Days to Decision 28 days
Submission Type Special
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
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
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 - KPS System, Tomography, Computed, Emission

All 367
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K071068.
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