K223491 is an FDA 510(k) clearance for the Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite. This device is classified as a Radiological Computer Assisted Detection/diagnosis Software For Fracture (Class II - Special Controls, product code QBS).
Submitted by Ge Medical Systems, LLC (Waukesha, US). The FDA issued a Cleared decision on May 25, 2023, 185 days after receiving the submission on November 21, 2022.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2090. 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..
| 510(k) Number | K223491 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 2022 |
| Decision Date | May 25, 2023 |
| Days to Decision | 185 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | QBS — Radiological Computer Assisted Detection/diagnosis Software For Fracture |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2090 |
| Definition | 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. |