SC+ AI Software

SC+ AI Software
N/A - 0894000004

An application software program intended to be used for estimation of the quantity of external blood loss during a surgical procedure by analysis of images of blood-laden absorptive devices (e.g., swabs) and suction canisters. It is intended to run on an off-the-shelf or dedicated portable computerized device (e.g., smartphone, tablet, laptop) which may require an Internet connection. It does not store any patient demographic or clinical data. It typically includes upgrades to the software.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PBZ

Device Name: Image Processing Device For Estimation Of External Blood Loss

Device Class: 2

Physical State: Software and Hardware system.

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.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: A software algorithm analyzes recorded images of surgical sponges to estimate hemoglobin mass.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: General Surgery

Regulation Number: 880.2750

Third Party Flag: N

Medical Specialty: HO

Device Id: 07613327622782

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A