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FDA 510(k)

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400

K-Number: K082921 · 2009-02-17

ApplicantRad Source Technologies, Inc.
Decision Date2009-02-17
Product CodeMOT
DecisionSubstantially Equivalent

Device Summary

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 is the device name listed in this FDA 510(k) record. The listed applicant is Rad Source Technologies, Inc.. It received FDA 510(k) clearance on 2009-02-17 under 510(k) number K082921. The device is classified under product code MOT. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400?

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 is a medical device that received FDA 510(k) clearance on 2009-02-17. The listed applicant is Rad Source Technologies, Inc.. The 510(k) number is K082921.

When did RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 receive FDA 510(k) clearance?

RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 received FDA 510(k) clearance on 2009-02-17, under 510(k) number K082921.

Who is the listed applicant for RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400?

The FDA 510(k) record lists Rad Source Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400?

The FDA product code for RAD SOURCE X-RAY BLOOD IRRADIATOR, MODEL RS-3400 is MOT.

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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 LimitedK051065RAYCELL X-RAY BLOOD IRRADIATORMds NordionK050963GAMMACELL 1000 ELITE AND GAMMACELL 3000 ELANMds Nordion

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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