FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Brainomix 360 Hyperdensity
K Number: K260406
·
Decision Jun 12, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
13
Review Days
123
Basic Information
- Device Name
- Brainomix 360 Hyperdensity
- K Number
- K260406
- 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
- February 9, 2026
- Decision Date
- June 12, 2026
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
Synapse PACS (7.6.0)
FDA 510(k)
FDA Class 2
·Radiology
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
DEEPVESSEL Plaque
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Brainomix Limited
| K Number | Device Name | ||
|---|---|---|---|
| K251983 | Brainomix 360 Triage Stroke | Aug 26, 2025 | Substantially Equivalent |
| 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 |
| K223555 | Brainomix 360 e-CTP | Jun 1, 2023 | Substantially Equivalent |