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FDA 510(k)

PICA WHOLE-BODY MRI SYSTEM

K-Number: K110942 · 2011-07-26

ApplicantTime Medical Limited
Decision Date2011-07-26
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PICA WHOLE-BODY MRI SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Time Medical Limited. It received FDA 510(k) clearance on 2011-07-26 under 510(k) number K110942. 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 PICA WHOLE-BODY MRI SYSTEM?

PICA WHOLE-BODY MRI SYSTEM is a medical device that received FDA 510(k) clearance on 2011-07-26. The listed applicant is Time Medical Limited. The 510(k) number is K110942.

When did PICA WHOLE-BODY MRI SYSTEM receive FDA 510(k) clearance?

PICA WHOLE-BODY MRI SYSTEM received FDA 510(k) clearance on 2011-07-26, under 510(k) number K110942.

Who is the listed applicant for PICA WHOLE-BODY MRI SYSTEM?

The FDA 510(k) record lists Time Medical Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PICA WHOLE-BODY MRI SYSTEM?

The FDA product code for PICA WHOLE-BODY MRI SYSTEM is LNH.

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Other records listing Time Medical Limited 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.

K222259NEONA 1.5T MRI SystemK183621EMMA 1.5T MRI SystemK093984PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01K092230MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01K091580PICA WHOLE BODY MRI SYSTEM

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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