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FDA 510(k)

PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01

K-Number: K093984 · 2010-03-24

ApplicantTime Medical Limited
Decision Date2010-03-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 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 2010-03-24 under 510(k) number K093984. 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 MODEL TMS-MRI-3500WB-01?

PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 is a medical device that received FDA 510(k) clearance on 2010-03-24. The listed applicant is Time Medical Limited. The 510(k) number is K093984.

When did PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 receive FDA 510(k) clearance?

PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 received FDA 510(k) clearance on 2010-03-24, under 510(k) number K093984.

Who is the listed applicant for PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01?

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 MODEL TMS-MRI-3500WB-01?

The FDA product code for PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 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 SystemK110942PICA WHOLE-BODY MRI SYSTEMK092230MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01K091580PICA WHOLE BODY MRI SYSTEM

Related Devices (Code: LNH)

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Official Source

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