Image Processing Device For Estimation Of External Blood Loss
PBZ is the FDA product code for Image Processing Device For Estimation Of External Blood Loss, a class II device type, regulated under 21 CFR 880.2750. FDA's definition for this code reads: "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...". As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and 4 recalls.
Classification record
- Product code
- PBZ
- Device name
- Image Processing Device For Estimation Of External Blood Loss
- FDA definition
- 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.
- Regulation
- 21 CFR 880.2750
- Device class
- Class II
- Review panel
- General Hospital
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 6
- Ingested recalls
- 4
Clearances, product code PBZ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2024 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code PBZ| Applicant | Clearances |
|---|---|
| Gauss Surgical, Inc. | 4 |
| Stryker Corp. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.