510(k) K233875
- Device
- Brainomix 360 e-Lung
- Applicant
- Brainomix Limited
- 510(k) number
- K233875
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-13
- Date received
- 2023-12-07
- Regulation
- 892.1750
- Classification name
- System, X-Ray, Tomography, Computed
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Thais Sala
- Address
- First Floor, Seacourt Tower West Way Oxford GB OX2JJ OX2JJ
FDA Registration Numbers#
- 3018596740
- 3017426576
- 2520313
- 3015223550
- 3008284470
- 8043933
- 3016007746
- 3012127758
- 3006894636
- 3010601176
- 3010281549
- 3015276088
- 3012085143
- 3009154005
- 3027373189
- 3015763655
- 3010326005
- 3011802799
- 3015232217
- 3006610845
- 3010642685
- 3011015597
- 3011950073
- 3008355361
- 3011396687
- 3003678543
- 3033527283
- 3011797532
- 3027338963
- 1066019
- 3011050570
- 3007545404
- 3014134519
- 3004993756
- 1811755
- 3004056159
- 3017500061
- 3005930550
- 3003094912
- 2126677
- 8022257
- 3023460764
- 3010703925
- 1000246715
- 3027245002
- 3015060224
- 3033527241
- 1423253
- 3002907620
- 3007562060
- 2183744
- 3005810333
- 3016965352
- 3004962788
- 3012044688
- 3033527273
- 3012957335
- 3003477135
- 1034973
- 3019216
- 2032112
- 3010789868
- 3032109181
- 3014938447
- 3014343100
- 2247992
- 1317307
- 3010398867
- 3002807636
- 3035950510
- 3004857110
- 3004091527
- 3033527282
- 3004977335
- 1047843
- 3023003446
- 3043512431
- 3013679558
- 3008007310
- 3026391023
Source Documents#
Other 510(k) Records For Product Code JAK#
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|---|---|---|---|
| K253450 | BodyTom Elite (NL4000) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| K253770 | CardIQ Suite | GE Medical Systems SCS | 2026-07-21 |
| K253560 | Enhanced Boundary for PCCT | Ge Medical Systems, LLC | 2026-06-24 |
| K253026 | Respiratory Gating for Scanners (2.1) | Varian Medical Systems, Inc. | 2026-06-04 |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0 | Canon Medical Systems Corporation | 2026-05-20 |
| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |