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FDA 510(k)

LINEAR ACCELERATOR THERAC 25

K-Number: K837347 · 1983-06-24

ApplicantAtomic Energy of Canada
Decision Date1983-06-24
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LINEAR ACCELERATOR THERAC 25 is the device name listed in this FDA 510(k) record. The listed applicant is Atomic Energy of Canada. It received FDA 510(k) clearance on 1983-06-24 under 510(k) number K837347. 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 LINEAR ACCELERATOR THERAC 25?

LINEAR ACCELERATOR THERAC 25 is a medical device that received FDA 510(k) clearance on 1983-06-24. The listed applicant is Atomic Energy of Canada. The 510(k) number is K837347.

When did LINEAR ACCELERATOR THERAC 25 receive FDA 510(k) clearance?

LINEAR ACCELERATOR THERAC 25 received FDA 510(k) clearance on 1983-06-24, under 510(k) number K837347.

Who is the listed applicant for LINEAR ACCELERATOR THERAC 25?

The FDA 510(k) record lists Atomic Energy of Canada as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINEAR ACCELERATOR THERAC 25?

The FDA product code for LINEAR ACCELERATOR THERAC 25 is IYE.

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Other records listing Atomic Energy of Canada 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.

K850543THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SYK837346MODEL GAMMACELL 1000K837152THERAC 25 LINEAR ACCELERATORK771260LINEAR ACCELERATOR G-2900K771096TELHTHERAPY SIMULATOR AECL-CP, G-3200

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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