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FDA 510(k)

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY

K-Number: K850543 · 1985-05-10

ApplicantAtomic Energy of Canada
Decision Date1985-05-10
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY 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 1985-05-10 under 510(k) number K850543. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY?

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Atomic Energy of Canada. The 510(k) number is K850543.

When did THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY receive FDA 510(k) clearance?

THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY received FDA 510(k) clearance on 1985-05-10, under 510(k) number K850543.

Who is the listed applicant for THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY?

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 THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY?

The FDA product code for THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY is IWB.

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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.

K837346MODEL GAMMACELL 1000K837347LINEAR ACCELERATOR THERAC 25K837152THERAC 25 LINEAR ACCELERATORK771260LINEAR ACCELERATOR G-2900K771096TELHTHERAPY SIMULATOR AECL-CP, G-3200

Related Devices (Code: IWB)

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.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, Inc.

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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