MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
FDA 510(k) clearance K011493 · decided 2002-10-01
Clearance details
- K-number
- K011493
- Device name
- MENTOR ISOLOADER AUTOMATIC NEEDLE LOADING SYSTEM AND PHYSICS WORKSTATION FOR BRACHYTHERAPY
- Applicant
- Mentor Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-05-15
- Decision date
- 2002-10-01
- Days to decision
- 504 days
- Clearance type
- Traditional
- Product code
- KPT
- Device class
- 2
- Regulation number
- 892.1360
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Eden Prairie, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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