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FDA 510(k)

MODEL GAMMACELL 1000

K-Number: K837346 · 1983-06-24

ApplicantAtomic Energy of Canada
Decision Date1983-06-24
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

MODEL GAMMACELL 1000 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 K837346. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL GAMMACELL 1000?

MODEL GAMMACELL 1000 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 K837346.

When did MODEL GAMMACELL 1000 receive FDA 510(k) clearance?

MODEL GAMMACELL 1000 received FDA 510(k) clearance on 1983-06-24, under 510(k) number K837346.

Who is the listed applicant for MODEL GAMMACELL 1000?

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 MODEL GAMMACELL 1000?

The FDA product code for MODEL GAMMACELL 1000 is MOT.

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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 SYK837347LINEAR ACCELERATOR THERAC 25K837152THERAC 25 LINEAR ACCELERATORK771260LINEAR ACCELERATOR G-2900K771096TELHTHERAPY SIMULATOR AECL-CP, G-3200

Related Devices (Code: MOT)

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.

K201177RadGil2R3 X-Ray L.L.CK181737Raycell MK1Best Theratronics LimitedK172087SANGRAYHitachi , Ltd.K161324Raycell Mk2Best Theratronics LimitedK082921RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400Rad Source Technologies, Inc.K051065RAYCELL X-RAY BLOOD IRRADIATORMds Nordion

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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