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Standard Imaging StructSure Software
STANDARD IMAGING INC. · Model 91340 · UDI-DI 00866562000281
LHO
Prescription
8
510(k) clearances
8
Adverse events
2
Recalls
61
Facilities
Description
Standard Imaging StructSure Software is designed to be used to assess the anatomical capabilities of: 1) clinical professionals who are responsible for contouring organs-at-risk and target volumes, i.e. manual contouring; and 2) automated contouring software systems, i.e. auto-segmentation.
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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