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FDA 510(k)

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005

K-Number: K003206 · 2001-04-25

ApplicantProxima Therapeutics, Inc.
Decision Date2001-04-25
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 is the device name listed in this FDA 510(k) record. The listed applicant is Proxima Therapeutics, Inc.. It received FDA 510(k) clearance on 2001-04-25 under 510(k) number K003206. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005?

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 is a medical device that received FDA 510(k) clearance on 2001-04-25. The listed applicant is Proxima Therapeutics, Inc.. The 510(k) number is K003206.

When did GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 receive FDA 510(k) clearance?

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 received FDA 510(k) clearance on 2001-04-25, under 510(k) number K003206.

Who is the listed applicant for GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005?

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

What is the FDA product code for GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005?

The FDA product code for GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005 is KXK.

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Other records listing Proxima Therapeutics, 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.

K041929MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYK032067MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYK030558MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAYK011690MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY

Related Devices (Code: KXK)

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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