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FDA 510(k)

CLINAC 20 (OPTIONAL 18 MV VERSION)

K-Number: K781057 · 1978-07-17

ApplicantVarian Assoc., Inc.
Decision Date1978-07-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CLINAC 20 (OPTIONAL 18 MV VERSION) is the device name listed in this FDA 510(k) record. The listed applicant is Varian Assoc., Inc.. It received FDA 510(k) clearance on 1978-07-17 under 510(k) number K781057. 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 CLINAC 20 (OPTIONAL 18 MV VERSION)?

CLINAC 20 (OPTIONAL 18 MV VERSION) is a medical device that received FDA 510(k) clearance on 1978-07-17. The listed applicant is Varian Assoc., Inc.. The 510(k) number is K781057.

When did CLINAC 20 (OPTIONAL 18 MV VERSION) receive FDA 510(k) clearance?

CLINAC 20 (OPTIONAL 18 MV VERSION) received FDA 510(k) clearance on 1978-07-17, under 510(k) number K781057.

Who is the listed applicant for CLINAC 20 (OPTIONAL 18 MV VERSION)?

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

What is the FDA product code for CLINAC 20 (OPTIONAL 18 MV VERSION)?

The FDA product code for CLINAC 20 (OPTIONAL 18 MV VERSION) is 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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