HyperVue™ Imaging System - Integrated
FDA 510(k) clearance K253101 · decided 2025-12-15
Clearance details
- K-number
- K253101
- Device name
- HyperVue™ Imaging System - Integrated
- Applicant
- Spectrawave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-09-24
- Decision date
- 2025-12-15
- Days to decision
- 82 days
- Clearance type
- Traditional
- Product code
- NQQ
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.