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FDA 510(k)

MHI-TM2000 LINEAR ACCELERATOR SYSTEM

K-Number: K072047 · 2007-08-29

ApplicantMitsubishi Heavy Industries, Ltd.
Decision Date2007-08-29
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MHI-TM2000 LINEAR ACCELERATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mitsubishi Heavy Industries, Ltd.. It received FDA 510(k) clearance on 2007-08-29 under 510(k) number K072047. 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 MHI-TM2000 LINEAR ACCELERATOR SYSTEM?

MHI-TM2000 LINEAR ACCELERATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-29. The listed applicant is Mitsubishi Heavy Industries, Ltd.. The 510(k) number is K072047.

When did MHI-TM2000 LINEAR ACCELERATOR SYSTEM receive FDA 510(k) clearance?

MHI-TM2000 LINEAR ACCELERATOR SYSTEM received FDA 510(k) clearance on 2007-08-29, under 510(k) number K072047.

Who is the listed applicant for MHI-TM2000 LINEAR ACCELERATOR SYSTEM?

The FDA 510(k) record lists Mitsubishi Heavy Industries, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MHI-TM2000 LINEAR ACCELERATOR SYSTEM?

The FDA product code for MHI-TM2000 LINEAR ACCELERATOR SYSTEM is IYE.

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Other records listing Mitsubishi Heavy Industries, Ltd. 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.

K122450MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

Related Devices (Code: IYE)

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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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