Rapid LVO
FDA 510(k) clearance K200941 · decided 2020-07-09
Clearance details
- K-number
- K200941
- Device name
- Rapid LVO
- Applicant
- Ischemaview, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-04-08
- Decision date
- 2020-07-09
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- QAS
- Device class
- 2
- Regulation number
- 892.2080
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Golden, CO, US
- Third-party review
- No
- Expedited review
- No
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| Scaida BrainCT-ICH (v1.0) (K250694) | Mlhealth 360 | 2025-11-25 |
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Recalls involving this device
No recalls on record reference this clearance.