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FDA 510(k)

EXL-14 MEDICAL LINEAR ACCELERATOR

K-Number: K880200 · 1988-08-04

ApplicantMitsubishi Intl. Corp.
Decision Date1988-08-04
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXL-14 MEDICAL LINEAR ACCELERATOR 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 1988-08-04 under 510(k) number K880200. 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 EXL-14 MEDICAL LINEAR ACCELERATOR?

EXL-14 MEDICAL LINEAR ACCELERATOR is a medical device that received FDA 510(k) clearance on 1988-08-04. The listed applicant is Mitsubishi Intl. Corp.. The 510(k) number is K880200.

When did EXL-14 MEDICAL LINEAR ACCELERATOR receive FDA 510(k) clearance?

EXL-14 MEDICAL LINEAR ACCELERATOR received FDA 510(k) clearance on 1988-08-04, under 510(k) number K880200.

Who is the listed applicant for EXL-14 MEDICAL LINEAR ACCELERATOR?

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 EXL-14 MEDICAL LINEAR ACCELERATOR?

The FDA product code for EXL-14 MEDICAL LINEAR ACCELERATOR is IYE.

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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.

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Related Devices (Code: IYE)

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Official Source

View on FDA Database →

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

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