Cleared Traditional

PET VCAR (K211247) - FDA 510(k) Clearance

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

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

Submission Details

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.

Device Classification

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 177
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