510(k) K223491
- Device
- Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite
- Applicant
- Ge Medical Systems, LLC
- 510(k) number
- K223491
- Product code
- QBS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-25
- Date received
- 2022-11-21
- Regulation
- 892.2090
- Classification name
- Radiological Computer Assisted Detection/Diagnosis Software For Fracture
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Chris Paulik
- Address
- 3000 N. Grandview Blvd. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 9616047
- 2126677
- 3026753394
- 3027453703
- 3014661828
- 3013427569
- 3021907554
- 3007734888
Source Documents#
Other 510(k) Records For Product Code QBS#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260378 | Rayvolve | AZmed | 2026-05-12 |
| K242171 | TechCare Trauma | Milvue | 2025-01-17 |
| K240712 | icobrain aria | Icometrix NV | 2024-11-07 |
| K240845 | Rayvolve | Azmed Sas | 2024-07-17 |
| K222176 | BoneView | Gleamer | 2023-03-02 |
| K220164 | Rayvolve | Azmed Sas | 2022-06-02 |
| K212365 | BoneView | Gleamer | 2022-03-01 |
| K193417 | FractureDetect (FX) | Imagen Technologies, Inc. | 2020-07-30 |
| DEN180005 | OsteoDetect | Imagen Technologies, Inc. | 2018-05-24 |