CLISIS SYSTEMS, Discovery RF180
FDA 510(k) clearance K213081 · decided 2021-10-26
Clearance details
- K-number
- K213081
- Device name
- CLISIS SYSTEMS, Discovery RF180
- Applicant
- General Medical Merate S.P.A
- Decision
- Substantially Equivalent
- Date received
- 2021-09-23
- Decision date
- 2021-10-26
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- IZF
- Device class
- 2
- Regulation number
- 892.1740
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Seriate, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.