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FDA 510(k)

LINAC-BASED STEROTACTIC RADIOSURGERY

K-Number: K923522 · 1993-08-18

ApplicantRadionics Software Applications, Inc.
Decision Date1993-08-18
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINAC-BASED STEROTACTIC RADIOSURGERY is the device name listed in this FDA 510(k) record. The listed applicant is Radionics Software Applications, Inc.. It received FDA 510(k) clearance on 1993-08-18 under 510(k) number K923522. 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 LINAC-BASED STEROTACTIC RADIOSURGERY?

LINAC-BASED STEROTACTIC RADIOSURGERY is a medical device that received FDA 510(k) clearance on 1993-08-18. The listed applicant is Radionics Software Applications, Inc.. The 510(k) number is K923522.

When did LINAC-BASED STEROTACTIC RADIOSURGERY receive FDA 510(k) clearance?

LINAC-BASED STEROTACTIC RADIOSURGERY received FDA 510(k) clearance on 1993-08-18, under 510(k) number K923522.

Who is the listed applicant for LINAC-BASED STEROTACTIC RADIOSURGERY?

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

What is the FDA product code for LINAC-BASED STEROTACTIC RADIOSURGERY?

The FDA product code for LINAC-BASED STEROTACTIC RADIOSURGERY is IYE.

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Other records listing Radionics Software Applications, Inc. as applicant

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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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