510(k) K203225
- Device
- Aquilion ONE (TSX-306A/3) V10.4 With Spectral Imaging System
- Applicant
- Canon Medical Systems Corporation
- 510(k) number
- K203225
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-03-24
- Date received
- 2020-11-02
- 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
- Paul Biggins
- Address
- 1385 Shimoishigami Otawara-Shi JP 324-8550 324-8550
FDA Registration Numbers#
- 3006894636
- 3026391023
- 3011416394
- 3029521953
- 1000246715
- 2032112
- 1317307
- 3015060224
- 8043933
- 3027245002
- 3004977335
- 3009543051
- 9612283
- 3011802799
- 1811755
- 3001722928
- 9613445
- 3013875850
- 3000126629
- 3032109181
- 3008355361
- 9614698
- 3004056159
- 3003967489
- 3018596740
- 3010789868
- 1034973
- 3005930550
- 9611343
- 3015223550
- 3018423337
- 3014134519
- 3032109225
- 8022257
- 3009154005
- 3010281549
- 2183744
- 3005156333
- 8043728
- 3004091527
- 3006487372
- 3031503890
- 3011786147
- 3012938564
- 3011797532
- 3011642792
- 3007797756
- 3006610845
- 3023003446
- 3027338963
- 3018094310
- 3012761544
- 3023140882
- 3004993756
- 3006209933
- 3023460764
- 3005877899
- 3006621332
- 1834003
- 3030982377
- 9616567
- 3012453401
- 3049422862
- 3013679558
- 3015232217
- 3008114965
- 1123169
- 3017425975
- 3027373189
- 3009963139
- 3014938447
- 3027339477
- 3003768277
- 3043512431
- 3014343100
- 3017894900
- 3003094912
- 3011950073
- 9613299
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260391 | AVIEW Aorta Metrics | Coreline Soft Co., Ltd. | 2026-10-16 |
| K261225 | CAS-One IR | Cascination AG | 2026-09-29 |
| K261125 | BodyTom 64 (NL4100); OmniTom Elite (NL5000) | Samsung HME America, Inc., dba NeuroLogica Corp. | 2026-09-22 |
| K261229 | SCENARIA View Phase 6.0 | Fujifilm Corporation | 2026-09-18 |
| K253836 | FCT iStream Phase 2 | Fujifilm Corporation | 2026-09-04 |
| 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 |
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