ADVANCED NUCLEAR COMPUTER
FDA 510(k) clearance K862842 · decided 1986-10-27
Clearance details
- K-number
- K862842
- Device name
- ADVANCED NUCLEAR COMPUTER
- Applicant
- Advanced Nuclear Imaging Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-29
- Decision date
- 1986-10-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LMB
- Device class
- 1
- Regulation number
- 892.2010
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Hollywood, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.