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FDA 510(k)

EXL-12SP,12DP,15DP,20DP LINAC

K-Number: K970137 · 1997-04-15

ApplicantMitsubishi Electronics America, Inc.
Decision Date1997-04-15
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXL-12SP,12DP,15DP,20DP LINAC 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 1997-04-15 under 510(k) number K970137. 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-12SP,12DP,15DP,20DP LINAC?

EXL-12SP,12DP,15DP,20DP LINAC is a medical device that received FDA 510(k) clearance on 1997-04-15. The listed applicant is Mitsubishi Electronics America, Inc.. The 510(k) number is K970137.

When did EXL-12SP,12DP,15DP,20DP LINAC receive FDA 510(k) clearance?

EXL-12SP,12DP,15DP,20DP LINAC received FDA 510(k) clearance on 1997-04-15, under 510(k) number K970137.

Who is the listed applicant for EXL-12SP,12DP,15DP,20DP LINAC?

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 EXL-12SP,12DP,15DP,20DP LINAC?

The FDA product code for EXL-12SP,12DP,15DP,20DP LINAC is IYE.

Related Clinical Trials

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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.

K973963120 LEAF MULTILEAF COLLIMATORK970564DYNAMIC WEDGE

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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