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FDA 510(k)

RAYCELL

K-Number: K032684 · 2003-09-26

ApplicantMds Nordion
Decision Date2003-09-26
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

RAYCELL is the device name listed in this FDA 510(k) record. The listed applicant is Mds Nordion. It received FDA 510(k) clearance on 2003-09-26 under 510(k) number K032684. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAYCELL?

RAYCELL is a medical device that received FDA 510(k) clearance on 2003-09-26. The listed applicant is Mds Nordion. The 510(k) number is K032684.

When did RAYCELL receive FDA 510(k) clearance?

RAYCELL received FDA 510(k) clearance on 2003-09-26, under 510(k) number K032684.

Who is the listed applicant for RAYCELL?

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?

The FDA product code for RAYCELL is MOT.

Related Clinical Trials

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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 IRRADIATORK050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANK010682HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEMK011246DCM 1.0K001006THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE

View all 7 devices →

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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