510(k) K163289
- Device
- Syngo. CT Single Source Dual Energy (twin Beam)
- Applicant
- SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI
- 510(k) number
- K163289
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-09
- Date received
- 2016-11-22
- 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
- Kimberly Mangum
- Address
- 40 Liberty Blvd. Mail Code 65-1a Malvern PA US 19355 19355
FDA Registration Numbers#
- 1226188
- 8043728
- 3030982377
- 3004993756
- 3008355361
- 3001722928
- 3008284470
- 3009196578
- 3015169361
- 8022257
- 3008496839
- 2134213
- 3007797756
- 3011396687
- 3019216
- 3007562060
- 3017500061
- 3009154005
- 3004091527
- 3010123525
- 3010789868
- 3015223550
- 3026391023
- 3012453401
- 3015777306
- 2011171
- 3033527241
- 2134850
- 3011015597
- 9611343
- 3010281549
- 3010642685
- 3006894636
- 2126677
- 3027373189
- 3010151377
- 1054713
- 3011050570
- 3029521953
- 3003967489
- 9613299
- 3015763655
- 3004198450
- 3021059265
- 3011797532
- 3004056159
- 3004977335
- 3012939903
- 3012044688
- 3035950510
- 3023003446
- 9614698
- 3017375271
- 3017894900
- 1811755
- 3014938447
- 3003575350
- 3010601176
- 3000126629
- 2134243
- 3039211310
- 1123169
- 3009529630
- 3032109181
- 3003202425
- 3008114965
- 1000246715
- 3027245002
- 3011416394
- 1317307
- 2247992
- 2030624
- 3014134519
- 3018094310
- 3015060224
- 3002808157
- 3018423337
- 9612283
- 3005877899
- 3033524251
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 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases