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FDA 510(k)

120 LEAF MULTILEAF COLLIMATOR

K-Number: K973963 · 1998-01-14

ApplicantMitsubishi Electronics America, Inc.
Decision Date1998-01-14
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

120 LEAF MULTILEAF COLLIMATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Electronics America, Inc.. It received FDA 510(k) clearance on 1998-01-14 under 510(k) number K973963. 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 120 LEAF MULTILEAF COLLIMATOR?

120 LEAF MULTILEAF COLLIMATOR is a medical device that received FDA 510(k) clearance on 1998-01-14. The listed applicant is Mitsubishi Electronics America, Inc.. The 510(k) number is K973963.

When did 120 LEAF MULTILEAF COLLIMATOR receive FDA 510(k) clearance?

120 LEAF MULTILEAF COLLIMATOR received FDA 510(k) clearance on 1998-01-14, under 510(k) number K973963.

Who is the listed applicant for 120 LEAF MULTILEAF COLLIMATOR?

The FDA 510(k) record lists Mitsubishi Electronics America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 120 LEAF MULTILEAF COLLIMATOR?

The FDA product code for 120 LEAF MULTILEAF COLLIMATOR is IYE.

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Other records listing Mitsubishi Electronics America, Inc. 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.

K970564DYNAMIC WEDGEK970137EXL-12SP,12DP,15DP,20DP LINAC

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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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