510(k) K191777
- Device
- Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT With Apex Edition
- Applicant
- GE Medical Systems, LLC
- 510(k) number
- K191777
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-07-26
- Date received
- 2019-07-02
- Regulation
- 892.1750
- Classification name
- System, X-ray, Tomography, Computed
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Laura Turner
- Address
- 3000 N. Grandview Blvd. Waukesha WI US 53188 53188
FDA Registration Numbers#
- 3010151377
- 3018423337
- 3042172882
- 8043933
- 3011802799
- 3014134519
- 3035950510
- 3017894900
- 3027373189
- 3010398867
- 3023460764
- 3003678543
- 3010326005
- 3003477135
- 3017500061
- 3027339477
- 3003967489
- 3023003446
- 3023140882
- 8022257
- 3010703925
- 3010789868
- 3004056159
- 3017375271
- 3007233544
- 9616567
- 3004083736
- 3008114965
- 3012085143
- 3043512431
- 3016007746
- 1226188
- 2011171
- 3011950073
- 9612283
- 3015060224
- 2183744
- 3008355361
- 3008284470
- 3006209933
- 3010123525
- 2126677
- 3015276088
- 9613445
- 3039211310
- 3008496839
- 3006610845
- 1047843
- 1054713
- 3012127758
- 3012044688
- 3002807636
- 3007797756
- 3015169361
- 3004962788
- 3015763655
- 3017210169
- 3026047529
- 3036666444
- 3006621332
- 3029521953
- 2032112
- 3007545404
- 3014938447
- 3009154005
- 3006487372
- 3015537315
- 3003094912
- 3009077524
- 3011642792
- 3027245002
- 2134213
- 3011050570
- 3031503890
- 3033524251
- 1423253
- 3002907620
- 9611343
- 3012957335
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253686 | True Definition DL | Ge Healthcare Japan Corporation | 2026-03-23 |
| K252992 | CT Rembra RT; CT Areta RT; CT Rembra | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| K253574 | SOMATOM X.cite; SOMATOM X.ceed | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| 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 |
Legacy Summary#
summary
FDA Review#
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