Cleared Traditional

INGENUITY TF PET/MR (K103483) - FDA 510(k) Clearance

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

K103483 · Philips Healthcare (Cleveland) · Radiology device
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Nov 2011
Decision
362d
Days
Class 2
Risk

K103483 is an FDA 510(k) clearance for the INGENUITY TF PET/MR. Classified as Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance (product code OUO), Class II - Special Controls.

Submitted by Philips Healthcare (Cleveland) (Cleveland, US). The FDA issued a Cleared decision on November 23, 2011 after a review of 362 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Philips Healthcare (Cleveland) devices

Submission Details

510(k) Number K103483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date November 23, 2011
Days to Decision 362 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
255d slower than avg
Panel avg: 107d · This submission: 362d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
Definition Imager That Generates Both Both Magnetic Resonance (mr) And Positron Emission Tomography (pet) Images And Provides Registration And Fusion Of These Images. Pet And Mr Images Can Be Acquired Either Simultaneously Or Sequentially. Anatomical Mr Images Are Used For Pet Attenuation Correction.
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 - OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

All 12
Devices cleared under the same product code (OUO) and FDA review panel - the closest regulatory comparables to K103483.
Biograph mMR with syngo MR E11P system software
K163234 · Siemens Medical Solutions USA, Inc. · Feb 2017
SIGNA PET/MR
K163619 · Ge Medical Systems, LLC · Feb 2017
BIOGRAPH MMR
K133226 · Siemens Medical Solutions USA, Inc. · Nov 2013
BIOGRAPH MMR
K103429 · Siemens Medical Solutions USA, Inc. · Jun 2011