Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
FDA 510(k) clearance K231731 · decided 2023-08-21
Clearance details
- K-number
- K231731
- Device name
- Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4
- Applicant
- Mcgovern Medical School
- Decision
- Substantially Equivalent
- Date received
- 2023-06-13
- Decision date
- 2023-08-21
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- KPS
- Device class
- 2
- Regulation number
- 892.1200
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.