510(k) K223491
K223491 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite". The FDA issued a decision of Substantially Equivalent on May 25, 2023. The device falls under product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture), a Class II device regulated under 21 CFR 892.2090. Ge Medical Systems, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 25, 2023
- Date Received
- November 21, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Device Class
- Class II
- Regulation Number
- 892.2090
- Review Panel
- RA
- Submission Type
A radiological computer assisted detection and diagnostic software for suspected fracture is an image processing device intended to aid in the detection, localization, and/or characterization of fracture on acquired medical images (e.g. radiography, MR, CT). The device detects, identifies and/or characterizes fracture based on features or information extracted from images, and may provide information about the presence, location, and/or characteristics of the fracture to the user. Primary diagnostic and patient management decisions are made by the clinical user.