CALCIVIS Imaging System
FDA premarket approval P170029/S002 · decided 2023-11-17
Approval details
- PMA number
- P170029
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CALCIVIS Imaging System
- Generic name
- Caries detection product with drug or biologic
- Applicant
- Calcivis Limited
- Date received
- 2023-05-25
- Decision date
- 2023-11-17
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- QJX
- Advisory committee
- Dental
- Expedited review
- No
- Location
- Edinburgh
- Statement
- The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the premarket approval application (PMA) 180-day supplement, which requested approval for modifications to the device components to include the lens design, fluid delivery mechanism, wireless communication, dock chiller chamber, and applicator redesign. The proposed modifications are to produce a smaller handheld imaging system with added wireless communication for the ease
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