FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Brainomix 360 e-CTP
K Number: K223555
·
Decision Jun 1, 2023
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
185
Basic Information
- Device Name
- Brainomix 360 e-CTP
- K Number
- K223555
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainomix Limited
- Date Received
- November 28, 2022
- Decision Date
- June 1, 2023
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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Other Clearances by Brainomix Limited
| K Number | Device Name | ||
|---|---|---|---|
| K242411 | Brainomix 360 e-Lung | Feb 19, 2025 | Substantially Equivalent |
| K243294 | Brainomix 360 e-ASPECTS | Feb 14, 2025 | Substantially Equivalent |
| K242123 | Brainomix 360 e-CTA | Jan 6, 2025 | Substantially Equivalent |
| K233875 | Brainomix 360 e-Lung | May 13, 2024 | Substantially Equivalent |
| K232496 | Brainomix 360 Triage Stroke | Nov 21, 2023 | Substantially Equivalent |
| K231837 | Brainomix 360 Triage LVO | Sep 28, 2023 | Substantially Equivalent |
| K231656 | Brainomix 360 e-MRI | Aug 30, 2023 | Substantially Equivalent |
| K231195 | Brainomix 360 Triage ICH | Jul 27, 2023 | Substantially Equivalent |
| K221564 | Brainomix 360 e-ASPECTS | Feb 23, 2023 | Substantially Equivalent |
| K192692 | Brainomix 360 e-CTA | May 28, 2020 | Substantially Equivalent |