SUN 125C IONIZATION CHAMBER
FDA 510(k) clearance K112981 · decided 2012-01-25
Clearance details
- K-number
- K112981
- Device name
- SUN 125C IONIZATION CHAMBER
- Applicant
- Sun Nuclear Corp.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-06
- Decision date
- 2012-01-25
- Days to decision
- 111 days
- Clearance type
- Traditional
- Product code
- LHN
- Device class
- 2
- Regulation number
- 892.5050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Melbourne, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.