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Standard Imaging TomoElectrometer

STANDARD IMAGING INC. · Model 90016 · UDI-DI 00850019946222

LHO Prescription
8
510(k) clearances
8
Adverse events
2
Recalls
61
Facilities

Description

Standard Imaging TomoElectrometer is a 8-channel electrometer designed to be connected to a radiation detector, (ionization chamber, well chamber, or diode detector), and measure the electrical current produced by the detector during irradiation.

Recalls

DateFirmReason
2024-02-08LandauerPermanent discontinuance of the microSTARii medical dosimetry system. Landauer has initiated this action to remove all reference to use of the microStar readers with the nanoDot o
2020-06-23Mevion Medical Systems, Inc.The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.