Qangio XA 3D
FDA 510(k) clearance K182611 · decided 2019-05-30
Clearance details
- K-number
- K182611
- Device name
- Qangio XA 3D
- Applicant
- Medis Medical Imaging Systems BV
- Decision
- Substantially Equivalent
- Date received
- 2018-09-21
- Decision date
- 2019-05-30
- Days to decision
- 251 days
- Clearance type
- Traditional
- Product code
- QHA
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Leiden, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.