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FDA 510(k)

RAYCELL X-RAY BLOOD IRRADIATOR

K-Number: K051065 · 2005-05-26

ApplicantMds Nordion
Decision Date2005-05-26
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

RAYCELL X-RAY BLOOD IRRADIATOR is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2005-05-26 under 510(k) number K051065. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYCELL X-RAY BLOOD IRRADIATOR?

RAYCELL X-RAY BLOOD IRRADIATOR is a medical device that received FDA 510(k) clearance on 2005-05-26. The listed applicant is Mds Nordion. The 510(k) number is K051065.

When did RAYCELL X-RAY BLOOD IRRADIATOR receive FDA 510(k) clearance?

RAYCELL X-RAY BLOOD IRRADIATOR received FDA 510(k) clearance on 2005-05-26, under 510(k) number K051065.

Who is the listed applicant for RAYCELL X-RAY BLOOD IRRADIATOR?

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 RAYCELL X-RAY BLOOD IRRADIATOR?

The FDA product code for RAYCELL X-RAY BLOOD IRRADIATOR 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.

K060870AVANZAK050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANK032684RAYCELLK010682HELAX-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.K050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANMds 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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