SIS System
FDA 510(k) clearance K241083 · decided 2024-06-14
Clearance details
- K-number
- K241083
- Device name
- SIS System
- Applicant
- Surgical Information Sciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-19
- Decision date
- 2024-06-14
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- QIH
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Edina, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.