Pixel 3 System

No FDA recalls found in the data synced 5 Oct 2026.

De Novo Number

DEN130015 ↗

FDA Product Code

PBZ

Device Class

Class II

Regulation

21 CFR Part 880.2750

Advisory Committee

General Hospital

FDA Decision

DENG De Novo granted

• Triton Canister System Open recall

  Class II

  FDA 510(k) K142801 Active Cleared 12 Mar 2015

• Triton System

  Class II

  FDA 510(k) K160338 Active Cleared 5 Aug 2016

• Pixel App

  Class I

  FDA 510(k) K120473 Active Cleared 9 Apr 2012

• Triton Sponge System

  Class II

  FDA 510(k) K163507 Active Cleared 25 Apr 2017

• Pixel App

  Class I

  FDA 510(k) K121274 Active Cleared 27 Jun 2012

• What is the Pixel 3 System used for?

  The Pixel 3 System is designed as an adjunctive tool for estimating external blood loss during surgical procedures. It analyzes pre-validated sponges using software and hardware to measure hemoglobin (Hb) mass, which can then be correlated with user-input patient data to derive an estimated blood volume. This helps clinicians monitor and manage blood loss intraoperatively in general and plastic surgery settings.

• Is the Pixel 3 System reusable or single-use?

  The Pixel 3 System is supplied as a reusable device. It consists of validated software, hardware, and accessory components that are intended for repeated use in sterile surgical environments. The system requires compatibility with pre-validated sponges and accessories to ensure accurate blood loss estimation.

• How does sterility work with the Pixel 3 System?

  The Pixel 3 System is intended for use in sterile surgical environments, but it is not explicitly certified for sterility beyond standard surgical practices. The reusable hardware and accessories must be handled and processed according to established surgical sterilization protocols to maintain a sterile field during use.

• What regulatory clearance does the Pixel 3 System have?

  The Pixel 3 System holds FDA 510(k) clearance under the designation DEN130015, classifying it as a Class 2 medical device. This clearance confirms its compliance with U.S. regulatory standards for use as an image processing device for estimating external blood loss in surgical settings.

• Does the Pixel 3 System require specific sponge or accessory compatibility?

  Yes, the Pixel 3 System is designed to work only with pre-validated sponges and accessories. These components must meet the system’s specifications to ensure accurate hemoglobin mass estimation and reliable blood loss quantification. Using non-compatible sponges or accessories may compromise the device’s performance.