NVISION VLE IMAGING SYSTEM
FDA 510(k) clearance K120800 · decided 2013-04-25
Clearance details
- K-number
- K120800
- Device name
- NVISION VLE IMAGING SYSTEM
- Applicant
- Ninepoint Medical, Inc.
- Decision
- Unknown
- Date received
- 2012-03-16
- Decision date
- 2013-04-25
- Days to decision
- 405 days
- Clearance type
- Traditional
- Product code
- NQQ
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hillsborough, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.