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FDA 510(k)

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS

K-Number: K122450 · 2012-10-03

ApplicantMitsubishi Heavy Industries, Ltd.
Decision Date2012-10-03
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS 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 2012-10-03 under 510(k) number K122450. 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 VERO IMAVIS?

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS is a medical device that received FDA 510(k) clearance on 2012-10-03. The listed applicant is Mitsubishi Heavy Industries, Ltd.. The 510(k) number is K122450.

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

MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS received FDA 510(k) clearance on 2012-10-03, under 510(k) number K122450.

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

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 VERO IMAVIS?

The FDA product code for MHI-TM2000 LINEAR ACCELERATOR SYSTEM VERO IMAVIS 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.

K072047MHI-TM2000 LINEAR ACCELERATOR SYSTEM

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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