FDA 510(k)

BRAINSCAN CONFORMAL RT MODULE

K-Number: K971367 · 1997-10-27

Decision Date1997-10-27

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

BRAINSCAN CONFORMAL RT MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 1997-10-27 under 510(k) number K971367. 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 BRAINSCAN CONFORMAL RT MODULE?

BRAINSCAN CONFORMAL RT MODULE is a medical device that received FDA 510(k) clearance on 1997-10-27. The listed applicant is Brainlab AG. The 510(k) number is K971367.

When did BRAINSCAN CONFORMAL RT MODULE receive FDA 510(k) clearance?

BRAINSCAN CONFORMAL RT MODULE received FDA 510(k) clearance on 1997-10-27, under 510(k) number K971367.

Who is the listed applicant for BRAINSCAN CONFORMAL RT MODULE?

The FDA 510(k) record lists Brainlab AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BRAINSCAN CONFORMAL RT MODULE?

The FDA product code for BRAINSCAN CONFORMAL RT MODULE 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.