FDA 510(k)

MM-22 MICROTRON, MM50 MICROTRON

K-Number: K900434 · 1990-10-23

Decision Date1990-10-23

Product CodeIYE

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MM-22 MICROTRON, MM50 MICROTRON is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix, Inc.. It received FDA 510(k) clearance on 1990-10-23 under 510(k) number K900434. 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 MM-22 MICROTRON, MM50 MICROTRON?

MM-22 MICROTRON, MM50 MICROTRON is a medical device that received FDA 510(k) clearance on 1990-10-23. The listed applicant is Scanditronix, Inc.. The 510(k) number is K900434.

When did MM-22 MICROTRON, MM50 MICROTRON receive FDA 510(k) clearance?

MM-22 MICROTRON, MM50 MICROTRON received FDA 510(k) clearance on 1990-10-23, under 510(k) number K900434.

Who is the listed applicant for MM-22 MICROTRON, MM50 MICROTRON?

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

What is the FDA product code for MM-22 MICROTRON, MM50 MICROTRON?

The FDA product code for MM-22 MICROTRON, MM50 MICROTRON 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Scanditronix, Inc. as applicant

K934303RFA A-300 K942092DPD-3 K925133DPD-510 THERAPEUTIC RADIATION DOSIMETER K914926SCANDIPLAN - VERSION 338 K904753DIOLASE K843366SUPERPETT

View all 7 devices →

Related Devices (Code: IYE)

K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC K261718EZFluence (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 SA K253004LUNA 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.