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FDA 510(k)

MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR

K-Number: K874893 · 1988-02-17

ApplicantKeithley Instruments, Inc.
Decision Date1988-02-17
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR is the device name listed in this FDA 510(k) record. The listed applicant is Keithley Instruments, Inc.. It received FDA 510(k) clearance on 1988-02-17 under 510(k) number K874893. 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 MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR?

MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR is a medical device that received FDA 510(k) clearance on 1988-02-17. The listed applicant is Keithley Instruments, Inc.. The 510(k) number is K874893.

When did MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR receive FDA 510(k) clearance?

MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR received FDA 510(k) clearance on 1988-02-17, under 510(k) number K874893.

Who is the listed applicant for MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR?

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

What is the FDA product code for MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR?

The FDA product code for MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR is IYE.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Keithley Instruments, 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.

K942083ADVANCED THERAPY DOSIMETERK932598TN-RD-50K854110KEITHLEY MODEL 75100 & 75200

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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