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FDA 510(k)

THERAC 25

K-Number: K922276 · 1994-05-25

ApplicantTheratronics, Inc.
Decision Date1994-05-25
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THERAC 25 is the device name listed in this FDA 510(k) record. The listed applicant is Theratronics, Inc.. It received FDA 510(k) clearance on 1994-05-25 under 510(k) number K922276. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERAC 25?

THERAC 25 is a medical device that received FDA 510(k) clearance on 1994-05-25. The listed applicant is Theratronics, Inc.. The 510(k) number is K922276.

When did THERAC 25 receive FDA 510(k) clearance?

THERAC 25 received FDA 510(k) clearance on 1994-05-25, under 510(k) number K922276.

Who is the listed applicant for THERAC 25?

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

What is the FDA product code for THERAC 25?

The FDA product code for THERAC 25 is IYE.

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Other records listing Theratronics, Inc. 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.

K983917THERATRON ELITEK970236THERAPLAN PLUS VERSION 1.2K964606THERATRON 780EK964607THERATON 1000EK954679THERAPLAN PLUSK940237THERAPLAN V05B/ TP-11 V09B

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Related Devices (Code: IYE)

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.

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLCK261718EZFluence (RADEZ V2)Radformation, Inc.K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd.K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc.K252937ThinkQA 3Dosisoft SAK253004LUNA 3DLap GmbH Laser Applikationen

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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