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FDA 510(k)

MULTI LEAF COLLIMATOR

K-Number: K961214 · 1996-08-06

ApplicantMitsubishi Intl. Corp.
Decision Date1996-08-06
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MULTI LEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Intl. Corp.. It received FDA 510(k) clearance on 1996-08-06 under 510(k) number K961214. 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 MULTI LEAF COLLIMATOR?

MULTI LEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 1996-08-06. The listed applicant is Mitsubishi Intl. Corp.. The 510(k) number is K961214.

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

MULTI LEAF COLLIMATOR received FDA 510(k) clearance on 1996-08-06, under 510(k) number K961214.

Who is the listed applicant for MULTI LEAF COLLIMATOR?

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

What is the FDA product code for MULTI LEAF COLLIMATOR?

The FDA product code for 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 Mitsubishi Intl. Corp. 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.

K952314EXL-12SP & 12DP LINACK952108EXL-15DP & 20-DP LINACK880200EXL-14 MEDICAL LINEAR ACCELERATORK873398EXL-22DP X-RAY RADIATION THERAPY SYSTEM

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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