FDA Product Code PBZ: Image Processing Device For Estimation Of External Blood Loss
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.
Leading manufacturers include Stryker Instruments.
FDA 510(k) Cleared Image Processing Device For Estimation Of External Blood Loss Devices (Product Code PBZ)
About Product Code PBZ - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PBZ since 2014, with 5 receiving FDA clearance (average review time: 223 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for PBZ submissions have been consistent, averaging 237 days recently vs 220 days historically.
PBZ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →