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FDA 510(k)

ROTATING GAMMA SYSTEM INFINI (INFINI)

K-Number: K102533 · 2011-03-22

ApplicantMasep Medical Science & Tech.Development (Shenzhen
Decision Date2011-03-22
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ROTATING GAMMA SYSTEM INFINI (INFINI) is the device name listed in this FDA 510(k) record. The listed applicant is Masep Medical Science & Tech.Development (Shenzhen. It received FDA 510(k) clearance on 2011-03-22 under 510(k) number K102533. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROTATING GAMMA SYSTEM INFINI (INFINI)?

ROTATING GAMMA SYSTEM INFINI (INFINI) is a medical device that received FDA 510(k) clearance on 2011-03-22. The listed applicant is Masep Medical Science & Tech.Development (Shenzhen. The 510(k) number is K102533.

When did ROTATING GAMMA SYSTEM INFINI (INFINI) receive FDA 510(k) clearance?

ROTATING GAMMA SYSTEM INFINI (INFINI) received FDA 510(k) clearance on 2011-03-22, under 510(k) number K102533.

Who is the listed applicant for ROTATING GAMMA SYSTEM INFINI (INFINI)?

The FDA 510(k) record lists Masep Medical Science & Tech.Development (Shenzhen as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ROTATING GAMMA SYSTEM INFINI (INFINI)?

The FDA product code for ROTATING GAMMA SYSTEM INFINI (INFINI) is IWB.

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Related Devices (Code: IWB)

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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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