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FDA 510(k)

BRAINLAB MICRO MULTI-LEAF COLLIMATOR

K-Number: K970586 · 1997-05-12

ApplicantBrainlab Med. Computersysteme GmbH
Decision Date1997-05-12
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAINLAB MICRO MULTI-LEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Brainlab Med. Computersysteme GmbH. It received FDA 510(k) clearance on 1997-05-12 under 510(k) number K970586. 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 BRAINLAB MICRO MULTI-LEAF COLLIMATOR?

BRAINLAB MICRO MULTI-LEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 1997-05-12. The listed applicant is Brainlab Med. Computersysteme GmbH. The 510(k) number is K970586.

When did BRAINLAB MICRO MULTI-LEAF COLLIMATOR receive FDA 510(k) clearance?

BRAINLAB MICRO MULTI-LEAF COLLIMATOR received FDA 510(k) clearance on 1997-05-12, under 510(k) number K970586.

Who is the listed applicant for BRAINLAB MICRO MULTI-LEAF COLLIMATOR?

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

What is the FDA product code for BRAINLAB MICRO MULTI-LEAF COLLIMATOR?

The FDA product code for BRAINLAB MICRO MULTI-LEAF COLLIMATOR is IYE.

Related Clinical Trials

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.

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Other records listing Brainlab Med. Computersysteme GmbH 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.

K954861BRAINLAB CT/X-RAY LOCALIZERK952390BRAINLAB STEROTATIC HEADRINGK945903BRAINLAB MASK SYSTEMK934657BRAINLAB LINAC HARDWARE

Related Devices (Code: IYE)

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.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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