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FDA 510(k)

EXL-12SP & 12DP LINAC

K-Number: K952314 · 1996-01-17

ApplicantMitsubishi Intl. Corp.
Decision Date1996-01-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EXL-12SP & 12DP LINAC 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 1996-01-17 under 510(k) number K952314. 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 LINAC?

EXL-12SP & 12DP LINAC is a medical device that received FDA 510(k) clearance on 1996-01-17. The listed applicant is Mitsubishi Intl. Corp.. The 510(k) number is K952314.

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

EXL-12SP & 12DP LINAC received FDA 510(k) clearance on 1996-01-17, under 510(k) number K952314.

Who is the listed applicant for EXL-12SP & 12DP LINAC?

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-12SP & 12DP LINAC?

The FDA product code for EXL-12SP & 12DP LINAC 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.

K961214MULTI LEAF COLLIMATORK952108EXL-15DP & 20-DP LINACK880200EXL-14 MEDICAL LINEAR ACCELERATORK873398EXL-22DP X-RAY RADIATION THERAPY SYSTEM

Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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