Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
FDA 510(k) clearance K171303 · decided 2017-09-22
Clearance details
- K-number
- K171303
- Device name
- Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664
- Applicant
- University of Texas Medical School AT Houston, Texas
- Decision
- Substantially Equivalent
- Date received
- 2017-05-03
- Decision date
- 2017-09-22
- Days to decision
- 142 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.