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FDA 510(k)

COUCH FOR TOTAL BODY RADIATION

K-Number: K010063 · 2001-04-02

ApplicantArplay Medical S.A.
Decision Date2001-04-02
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COUCH FOR TOTAL BODY RADIATION is the device name listed in this FDA 510(k) record. The listed applicant is Arplay Medical S.A.. It received FDA 510(k) clearance on 2001-04-02 under 510(k) number K010063. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUCH FOR TOTAL BODY RADIATION?

COUCH FOR TOTAL BODY RADIATION is a medical device that received FDA 510(k) clearance on 2001-04-02. The listed applicant is Arplay Medical S.A.. The 510(k) number is K010063.

When did COUCH FOR TOTAL BODY RADIATION receive FDA 510(k) clearance?

COUCH FOR TOTAL BODY RADIATION received FDA 510(k) clearance on 2001-04-02, under 510(k) number K010063.

Who is the listed applicant for COUCH FOR TOTAL BODY RADIATION?

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

What is the FDA product code for COUCH FOR TOTAL BODY RADIATION?

The FDA product code for COUCH FOR TOTAL BODY RADIATION is IYE.

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Other records listing Arplay Medical S.A. 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.

K010065CRANIAL STEREOTACTIC EQUIPMENTK004023INTRA OPERATIVE RADIATION THERAPYK003779IMMOBILIZATION SYSTEM FOR ENTK003778BREAST-BOARD (MULTIPLE)K010174TRAY ADAPTERS, MULTIPLEK010172LEAD BLOCKS

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Related Devices (Code: IYE)

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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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