510(k) K152473
- Device
- CAS-One IR
- Applicant
- CAScination AG
- 510(k) number
- K152473
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-01-20
- Date received
- 2015-08-31
- 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
- Matthias Peterehans
- Address
- Steigerhubelstrasse 3 Bern CH 3008 3008
FDA Registration Numbers#
- 3013875850
- 3012957335
- 3015169361
- 3013679558
- 3017500061
- 3030982377
- 3013035022
- 3010281549
- 3005930550
- 3015763655
- 3010601176
- 3033524251
- 1000246715
- 2032112
- 3021059265
- 1811755
- 3011797532
- 3000126629
- 3007545404
- 3027338963
- 3008769756
- 9612283
- 9613299
- 3015276088
- 3002808157
- 3012453401
- 3003768277
- 3042175844
- 3014809646
- 3015777306
- 3003202425
- 3004938766
- 3005877899
- 3006894636
- 3036666444
- 3004198450
- 3018094310
- 3014938447
- 2247992
- 3039211310
- 3011642792
- 3006209933
- 3008496839
- 3010703925
- 2126677
- 3012085143
- 8022257
- 1047843
- 3004753774
- 1054713
- 3008632256
- 3008355361
- 3010642685
- 3015060224
- 3004857110
- 3004962788
- 9613445
- 3026047529
- 3007233544
- 3026391023
- 1034973
- 3016965352
- 1834003
- 3035950510
- 3010398867
- 3002907620
- 3010326005
- 3009077524
- 3043512431
- 3011416394
- 2183744
- 3008114965
- 9617978
- 2134850
- 3006621332
- 3042172882
- 3011802799
- 3031503890
- 3014653800
- 3008007310
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
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