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FDA 510(k)

THERAC 25 LINEAR ACCELERATOR

K-Number: K837152 · 1983-03-22

ApplicantAtomic Energy of Canada
Decision Date1983-03-22
Product CodeJAI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAC 25 LINEAR ACCELERATOR 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 1983-03-22 under 510(k) number K837152. The device is classified under product code JAI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAC 25 LINEAR ACCELERATOR?

THERAC 25 LINEAR ACCELERATOR is a medical device that received FDA 510(k) clearance on 1983-03-22. The listed applicant is Atomic Energy of Canada. The 510(k) number is K837152.

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

THERAC 25 LINEAR ACCELERATOR received FDA 510(k) clearance on 1983-03-22, under 510(k) number K837152.

Who is the listed applicant for THERAC 25 LINEAR ACCELERATOR?

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 THERAC 25 LINEAR ACCELERATOR?

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

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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 1000K837347LINEAR ACCELERATOR THERAC 25K771260LINEAR ACCELERATOR G-2900K771096TELHTHERAPY SIMULATOR AECL-CP, G-3200

Related Devices (Code: JAI)

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.

K231612Eve Patient Positioner SystemLeo Cancer CareK182683Z-Robot Patient Positioning SystemChinan Biomedical Technology, Inc.K170502Patient Positioning SystemForte Automation Systems, Inc.K160518LEONI ORION SystemLeoni Cia Cable SystemK132084PROTURA COUCH SOFTWAREMed-Tec, Inc. D/B/A Civco Medical SolutionsK122413PATIENT POSITIONING SYSTEMForte Automation Systems, Inc.

Official Source

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