Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION

K-Number: K113483 · 2012-09-26

ApplicantPhilips Healthcare (Cleveland)
Decision Date2012-09-26
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ITERATIVE RECONSTRUCTION TECHNIQUE 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 2012-09-26 under 510(k) number K113483. 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 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION?

ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION is a medical device that received FDA 510(k) clearance on 2012-09-26. The listed applicant is Philips Healthcare (Cleveland). The 510(k) number is K113483.

When did ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION receive FDA 510(k) clearance?

ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION received FDA 510(k) clearance on 2012-09-26, under 510(k) number K113483.

Who is the listed applicant for ITERATIVE RECONSTRUCTION TECHNIQUE 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 ITERATIVE RECONSTRUCTION TECHNIQUE SOFTWARE APPLICATION?

The FDA product code for ITERATIVE RECONSTRUCTION TECHNIQUE 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/CTK123576IMR 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

View on FDA Database →

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

↑