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FDA 510(k)

INGENUITY TF PET/MR

K-Number: K103483 · 2011-11-23

ApplicantPhilips Healthcare (Cleveland)
Decision Date2011-11-23
Product CodeOUO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INGENUITY TF PET/MR is the device name listed in this FDA 510(k) record. The listed applicant is Philips Healthcare (Cleveland). It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K103483. The device is classified under product code OUO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INGENUITY TF PET/MR?

INGENUITY TF PET/MR is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Philips Healthcare (Cleveland). The 510(k) number is K103483.

When did INGENUITY TF PET/MR receive FDA 510(k) clearance?

INGENUITY TF PET/MR received FDA 510(k) clearance on 2011-11-23, under 510(k) number K103483.

Who is the listed applicant for INGENUITY TF PET/MR?

The FDA 510(k) record lists Philips Healthcare (Cleveland) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INGENUITY TF PET/MR?

The FDA product code for INGENUITY TF PET/MR is OUO.

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Other records listing Philips Healthcare (Cleveland) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K131773BRILLIANCE ICTK123599INGENUITY DIGITAL PET/CTK123576IMR SOFTWARE APPLICATIONK113483ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION

Related Devices (Code: OUO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253963Cubresa BrainPETCubresa, Inc.K253023BIOGRAPH OneSiemens Healthineers AGK234154uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K222540uPMR 790Shanghai United Imaging Healthcare Co., Ltd.K213709SIGNA PET/MRGe Medical Systems, LLCK200213Biograph mMR with syngo MR E11P-AP01 system softwareSiemens Medical Solutions USA, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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