Cleared Traditional

K211247 - PET VCAR

K211247 is an FDA 510(k) clearance for PET VCAR, manufactured by GE Medical Systems SCS. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K211247 · GE Medical Systems SCS · Radiology device
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Jul 2021
Decision
92d
Days
Class 2
Risk

K211247 is an FDA 510(k) clearance for the PET VCAR. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by GE Medical Systems SCS (Buc, FR). The FDA issued a Cleared decision on July 27, 2021 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - 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 GE Medical Systems SCS devices

FDA 510(k) Submission Details - K211247

510(k) Number K211247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2021
Decision Date July 27, 2021
Days to Decision 92 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
15d faster than avg
Panel avg: 107d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 249
Devices cleared under the same product code (KPS) and FDA review panel - the closest regulatory comparables to K211247.
MyoSPECT, MyoSpect ES
K212004 · Ge Healthcare · Aug 2021
Discovery MI Gen2
K211846 · Ge Medical Systems, LLC · Aug 2021
Vereos PET/CT
K211764 · Philips Medical Systems Nederland B.V. · Aug 2021
Vereos PET/CT
K210880 · Philips Medical Systems Nederland B.V. · May 2021
Symbia VA10A Family
K210557 · Siemens Medical Solutions USA, Inc. · May 2021
HYPER AiR
K210001 · Shanghai United Imaging Healthcare Co., Ltd. · Apr 2021