FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Brainomix 360 e-Lung
K Number: K242411
·
Decision Feb 19, 2025
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
13
Review Days
189
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Brainomix 360 e-Lung
- K Number
- K242411
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brainomix Limited
- Date Received
- August 14, 2024
- Decision Date
- February 19, 2025
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Brainomix Limited
| K Number | Device Name | ||
|---|---|---|---|
| K260406 | Brainomix 360 Hyperdensity | Jun 12, 2026 | Substantially Equivalent |
| K251983 | Brainomix 360 Triage Stroke | Aug 26, 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 |