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FDA 510(k)

MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)

K-Number: K041125 · 2004-12-30

ApplicantMasep Med Science & Tech. Development (Shenzhen) C
Decision Date2004-12-30
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Masep Med Science & Tech. Development (Shenzhen) C. It received FDA 510(k) clearance on 2004-12-30 under 510(k) number K041125. 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 MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)?

MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) is a medical device that received FDA 510(k) clearance on 2004-12-30. The listed applicant is Masep Med Science & Tech. Development (Shenzhen) C. The 510(k) number is K041125.

When did MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) receive FDA 510(k) clearance?

MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) received FDA 510(k) clearance on 2004-12-30, under 510(k) number K041125.

Who is the listed applicant for MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)?

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

What is the FDA product code for MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM)?

The FDA product code for MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) is IWB.

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Related Devices (Code: IWB)

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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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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