510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K223491Substantially Equivalent

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

GE Healthcare, Waukesha WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K223491 is the FDA 510(k) clearance record for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite, a class II device, cleared for Ge Medical Systems, LLC on under FDA product code QBS (Radiological Computer Assisted Detection/Diagnosis Software For Fracture). FDA's definition for product code QBS reads: "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...". FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K223491.

Clearance record

Decision date
Received
(185 days to decision)
Product code
QBS Radiological Computer Assisted Detection/Diagnosis Software For Fracture
Regulation
21 CFR 892.2090
Device class
Class II
Review panel
Radiology
Applicant
Ge Medical Systems, LLC 3000 N. Grandview Blvd., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QBS

Trailing 12 months
2 clearances under product code QBS in the twelve months to October 2026, May 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QBS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260