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- PCSLiver Iron Concentration Imaging Companion Diagnostic For Deferasirox2Product Code
- PDKCream For X-Ray Attenuation2Product Code
- QBSRadiological Computer Assisted Detection/Diagnosis Software For Fracture2Product Code
- K240712icobrain aria2Cleared 510(K)
- K240845Rayvolve2Cleared 510(K)
- K223491Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite2Cleared 510(K)
- K222176BoneView2Cleared 510(K)
- K220164Rayvolve2Cleared 510(K)
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- DEN180005OsteoDetect2Cleared 510(K)
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- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
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Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K223491
- 510(k) Type
- Traditional
- Applicant
- GE Medical Systems, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/25/2023
- Days to Decision
- 185 days
- Submission Type
- Summary