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FDA 510(k)

IMR SOFTWARE APPLICATION

K-Number: K123576 · 2013-06-07

ApplicantPhilips Healthcare (Cleveland)
Decision Date2013-06-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IMR SOFTWARE APPLICATION 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 2013-06-07 under 510(k) number K123576. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMR SOFTWARE APPLICATION?

IMR SOFTWARE APPLICATION is a medical device that received FDA 510(k) clearance on 2013-06-07. The listed applicant is Philips Healthcare (Cleveland). The 510(k) number is K123576.

When did IMR SOFTWARE APPLICATION receive FDA 510(k) clearance?

IMR SOFTWARE APPLICATION received FDA 510(k) clearance on 2013-06-07, under 510(k) number K123576.

Who is the listed applicant for IMR SOFTWARE APPLICATION?

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 IMR SOFTWARE APPLICATION?

The FDA product code for IMR SOFTWARE APPLICATION is JAK.

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 ICTK123599INGENUITY DIGITAL PET/CTK113483ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATIONK103483INGENUITY TF PET/MR

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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