3 devices · 2 companies · 2016 to 2026
Product code PBZ: Image Processing Device For Estimation Of External Blood Loss
3 devices under product code PBZ, 2016 to 2026, from 2 companies. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (3 of 3 here), the regulation, and MAUDE report counts by product code.
Image Processing Device For Estimation Of External Blood Loss. 21 CFR 880.2750, Class II. An image processing device for estimation of external blood loss is a device to be used as an aid in estimation of patient external blood loss. The device may include software and/or hardware that is used to process images capturing externally lost blood to estimate the hemoglobin mass and/or the blood volume present in the images. MAUDE held 268 adverse-event reports against this product code as of 2026-10-29; reports are unverified and the code is shared by every device of this type.
Retrieved from FDA public records.
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Every device, newest decision first
| Decision | Device | Company | Panel | FDA |
|---|---|---|---|---|
| SurgiCount+ SystemK252282 · 510(k) | Stryker Instruments | General Hospital | database entry | |
| SurgiCount+ SystemK232250 · 510(k) | Stryker Instruments | General Hospital | database entry | |
| Triton SystemK160338 · 510(k) | GAUSS SURGICAL INC. | General Hospital | database entry |
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