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FDA 510(k)

BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0

K-Number: K061255 · 2006-06-13

ApplicantKyron Clinical Imaging, Inc.
Decision Date2006-06-13
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 is the device name listed in this FDA 510(k) record. The listed applicant is Kyron Clinical Imaging, Inc.. It received FDA 510(k) clearance on 2006-06-13 under 510(k) number K061255. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0?

BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 is a medical device that received FDA 510(k) clearance on 2006-06-13. The listed applicant is Kyron Clinical Imaging, Inc.. The 510(k) number is K061255.

When did BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 receive FDA 510(k) clearance?

BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 received FDA 510(k) clearance on 2006-06-13, under 510(k) number K061255.

Who is the listed applicant for BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0?

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

What is the FDA product code for BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0?

The FDA product code for BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 is LNH.

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.

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Other records listing Kyron Clinical Imaging, 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.

K063031PRISM VIEW, MODELK052467BRAIN VIEWRX VIEWER, VERSION 1.0

Related Devices (Code: LNH)

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.

K261758Embrace Vision Neonatal MRI SystemAspect Imaging, Ltd.K261283APERTO Lucent MRI SystemFujifilm CorporationK260758MAGNETOM Free.Max; MAGNETOM Free.StarSiemens Shenzhen Magnetic Resonance , Ltd.K262622Swoop® Portable MR Imaging® SystemHyperfine, Inc.K254250MagicScan-1.5, GreenMR Serenity 1.5TXingaoyi Medical Equipment Co.,LtdK253808AIR Recon DLGE Medical Systems

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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