HyperVue Imaging System— 510(k) K230691
Substantially EquivalentSpectrawave, Inc.
FDA 510(k) clearance K230691 for HyperVue Imaging System, Substantially Equivalent on 2023-06-07. Applicant: Spectrawave, Inc..
Clearance details
- Applicant
- Spectrawave, Inc.
- Product code
- Code NQQ
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.