Prelude
MedCom Gesellschaft für medizinische Bildverarbeitung mbH · Model V1. EBRT · UDI-DI 04260308110108
1
510(k) clearances
8
Adverse events
2
Recalls
61
Facilities
Description
The Prelude software supports radiation therapy workflows for IntraOp Mobetron, a radiation treatment device. It assists to find product specific machine parameters for treatment and can send those proposals to the console of the device. The machine parameters are not intended to be used for direct control for the radiation device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-02-08 | Landauer | Permanent 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 |
| 2020-06-23 | Mevion 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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Get your free API keyRead the docsData 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.