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FDA 510(k)

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN

K-Number: K050963 · 2005-05-20

ApplicantMds Nordion
Decision Date2005-05-20
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2005-05-20 under 510(k) number K050963. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN?

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN is a medical device that received FDA 510(k) clearance on 2005-05-20. The listed applicant is Mds Nordion. The 510(k) number is K050963.

When did GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN receive FDA 510(k) clearance?

GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN received FDA 510(k) clearance on 2005-05-20, under 510(k) number K050963.

Who is the listed applicant for GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN?

The FDA 510(k) record lists Mds Nordion as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN?

The FDA product code for GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELAN is MOT.

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Other records listing Mds Nordion 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.

K060870AVANZAK051065RAYCELL X-RAY BLOOD IRRADIATORK032684RAYCELLK010682HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEMK011246DCM 1.0K001006THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

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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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