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FDA 510(k)

EXACTRAC X-RAY X-RAY

K-Number: K120789 · 2012-08-14

ApplicantBrainlab AG
Decision Date2012-08-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXACTRAC X-RAY X-RAY is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab AG. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K120789. 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 EXACTRAC X-RAY X-RAY?

EXACTRAC X-RAY X-RAY is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Brainlab AG. The 510(k) number is K120789.

When did EXACTRAC X-RAY X-RAY receive FDA 510(k) clearance?

EXACTRAC X-RAY X-RAY received FDA 510(k) clearance on 2012-08-14, under 510(k) number K120789.

Who is the listed applicant for EXACTRAC X-RAY X-RAY?

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 EXACTRAC X-RAY X-RAY?

The FDA product code for EXACTRAC X-RAY X-RAY 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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