FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Viz ICH
K Number: K193658
·
Decision Mar 18, 2020
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
11
Review Days
79
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Basic Information
- Device Name
- Viz ICH
- K Number
- K193658
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Viz. Ai, Inc.
- Date Received
- December 30, 2019
- Decision Date
- March 18, 2020
- Product Code
- QAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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Other Clearances by Viz. Ai, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250354 | Viz Subdural+, Viz SUBDURAL PLUS | Jun 10, 2025 | Substantially Equivalent |
| K232363 | Viz HDS, Viz Volume Plus, Viz ICH+ | Feb 5, 2024 | Substantially Equivalent |
| DEN230003 | Viz HCM | Aug 3, 2023 | Unknown |
| K223443 | Viz AAA | Mar 17, 2023 | Substantially Equivalent |
| K223042 | Viz LVO ContaCT | Oct 21, 2022 | Substantially Equivalent |
| K221100 | Viz RV/LV | Aug 29, 2022 | Substantially Equivalent |
| K220439 | Viz SDH | Jul 25, 2022 | Substantially Equivalent |
| K213319 | Viz ANEURYSM, Viz ANX | Feb 18, 2022 | Substantially Equivalent |
| K210209 | Viz ICH | Mar 23, 2021 | Substantially Equivalent |
| K180161 | Viz CTP | Apr 20, 2018 | Substantially Equivalent |