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FDA 510(k)

ICT

K-Number: K130224 · 2013-07-18

ApplicantImris, Inc.
Decision Date2013-07-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ICT is the device name listed in this FDA 510(k) record. The listed applicant is Imris, Inc.. It received FDA 510(k) clearance on 2013-07-18 under 510(k) number K130224. 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 ICT?

ICT is a medical device that received FDA 510(k) clearance on 2013-07-18. The listed applicant is Imris, Inc.. The 510(k) number is K130224.

When did ICT receive FDA 510(k) clearance?

ICT received FDA 510(k) clearance on 2013-07-18, under 510(k) number K130224.

Who is the listed applicant for ICT?

The FDA 510(k) record lists Imris, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICT?

The FDA product code for ICT is JAK.

Related PubMed Literature

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.

PMID: 42632356Deployer-side governance of medical imaging artificial intelligence: the regulatory readiness instrument (RRI-MI) for multi-jurisdictional and post-market compliance.International journal of medical informatics ()PMID: 42375709Multimodal LLM vs. Human-Measured Features for AI Predictions of Autism in Home Videos.Algorithms ()PMID: 39568744Conflicting interpretations and FDA reputation: the case of post-market surveillance of breast implants.Frontiers in medicine ()PMID: 37948287TCCC Decision Support With Machine Learning Prediction of Hemorrhage Risk, Shock Probability.Military medicine ()

Other records listing Imris, Inc. 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.

K123091VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3TK121997IMRIS ONCOLOGY PACKAGEK113748IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD)K103493HEAD FIATION DEVICE (HFD 100)K1035061.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)K101813IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO

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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.

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