CURAY CUSTOM SEED ARRAY
FDA 510(k) clearance K053595 · decided 2006-02-28
Clearance details
- K-number
- K053595
- Device name
- CURAY CUSTOM SEED ARRAY
- Applicant
- Biolucent, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-23
- Decision date
- 2006-02-28
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- KXK
- Device class
- 2
- Regulation number
- 892.5730
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Aliso Viejo, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.