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FDA 510(k)

INGENUITY DIGITAL PET/CT

K-Number: K123599 · 2013-07-12

ApplicantPhilips Healthcare (Cleveland)
Decision Date2013-07-12
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INGENUITY DIGITAL PET/CT 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 2013-07-12 under 510(k) number K123599. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INGENUITY DIGITAL PET/CT?

INGENUITY DIGITAL PET/CT is a medical device that received FDA 510(k) clearance on 2013-07-12. The listed applicant is Philips Healthcare (Cleveland). The 510(k) number is K123599.

When did INGENUITY DIGITAL PET/CT receive FDA 510(k) clearance?

INGENUITY DIGITAL PET/CT received FDA 510(k) clearance on 2013-07-12, under 510(k) number K123599.

Who is the listed applicant for INGENUITY DIGITAL PET/CT?

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 DIGITAL PET/CT?

The FDA product code for INGENUITY DIGITAL PET/CT is KPS.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 ICTK123576IMR SOFTWARE APPLICATIONK113483ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATIONK103483INGENUITY TF PET/MR

Related Devices (Code: KPS)

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.

K261305MICSI-PETMicrostructure Imaging, Inc.K261427uMI Panvivo (uMI Panvivo M)Shanghai United Imaging Healthcare Co., Ltd.K261315Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 FamilySiemens Medical Solutions USA, Inc.K260524uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K253564uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)Shanghai United Imaging Healthcare Co., Ltd.K254001VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)Spectrum Dynamics Medical, Ltd.

Official Source

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

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