510(k) K230223
- Device
- iCAC Device
- Applicant
- Bunkerhill, Inc.
- 510(k) number
- K230223
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-04-25
- Date received
- 2023-01-26
- 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
Related Records
Applicant Contact
- Contact
- Nishith Khandwala
- Address
- 428 El Verano Ave. Palo Alto CA US 94306 94306
FDA Registration Numbers
- 3033527241
- 3030982377
- 3005810333
- 3010123525
- 3010601176
- 3036666444
- 3014343100
- 3027245002
- 3002807636
- 3011642792
- 3013035022
- 3010151377
- 8022257
- 2520313
- 3015777306
- 1226188
- 1423253
- 3015169361
- 3026970882
- 3004977335
- 3016965352
- 8043933
- 3011416394
- 3014134519
- 3007545404
- 3011050570
- 1047843
- 2032112
- 3002907620
- 3012453401
- 3021059265
- 1034973
- 2011171
- 3018094310
- 3009196578
- 3014246639
- 3002808157
- 3015537315
- 3003678543
- 3004962788
- 1000246715
- 3016007746
- 9611343
- 3012085143
- 3042175844
- 3008007310
- 3010398867
- 3033524251
- 3008355361
- 3023460764
- 3013875850
- 3013679558
- 3004083736
- 3009963139
- 3010703925
- 3023140882
- 3027373189
- 3007233544
- 3015276088
- 3011825597
- 3035950510
- 2134213
- 3039211310
- 3005930550
- 3014809646
- 3010642685
- 9614698
- 3001722928
- 3017425975
- 3006487372
- 2126677
- 3004091527
- 3027339477
- 3005877899
- 3009154005
- 9617978
- 3029521953
- 3015763655
- 3042172882
Source Documents
Other 510(k) Records For Product Code JAK
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|---|---|---|---|
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| K253649 | Spectral CT Verida Family | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
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| K253520 | Photonova Spectra, Photonova Spectra Select | Ge Medical Systems, LLC | 2026-03-20 |
| K260078 | Aquilion ServeSP (TSX-307B) V2.0 | Canon Medical Systems Corporation | 2026-03-13 |
| K252249 | Extremity CT Imaging System | Mars Bioimaging , Ltd. | 2026-03-13 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260166 | Bunkerhill Contrast CAC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |
| K253173 | uCT 780 with uWS-CT-Dual Energy Analysis | Shanghai United Imaging Healthcare Co., Ltd. | 2026-01-20 |
| K252217 | CT VScore+ | Canon Medical Informatics, Inc. | 2025-11-28 |
| K251805 | syngo.CT Dual Energy | Siemens Medical Solutions USA, Inc. | 2025-10-15 |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 |