510(k) K974307
- Device
- RTR-2000/RTR-4000
- Applicant
- TERARECON, INC.
- 510(k) number
- K974307
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-02-13
- Date received
- 1997-11-17
- 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
- TIM FRANDSEN
- Address
- 280 Utah Ave., Suite 100 South San Francisco CA US 94080 94080
FDA Registration Numbers#
- 3017425975
- 3004056159
- 3008632256
- 8022257
- 3003678543
- 3023003446
- 3033527283
- 3015223550
- 3017210169
- 9617978
- 3027339477
- 3001722928
- 3013679558
- 3019216
- 3017426576
- 1226188
- 3003967489
- 3023140882
- 3012761544
- 3006209933
- 9611343
- 3015777306
- 3033527273
- 2520313
- 3002808157
- 3042175844
- 3008355361
- 3004083736
- 3010398867
- 3012453401
- 3039211310
- 3005930550
- 3042172882
- 3012938564
- 8043933
- 3012044688
- 3004753774
- 3031503890
- 3004977335
- 3013035022
- 1811755
- 3036666444
- 3014653800
- 1423253
- 3004857110
- 1054713
- 3010703925
- 2134850
- 9613445
- 3003094912
- 3007545404
- 3011050570
- 3007562060
- 3008284470
- 8043728
- 3011642792
- 1066019
- 3002807636
- 3008496839
- 3033527282
- 3011825597
- 3012957335
- 3004993756
- 3009529630
- 3010151377
- 3008769756
- 1034973
- 3014246639
- 3032109225
- 3015276088
- 3015763655
- 3007225492
- 3011416394
- 3011786147
- 3021059265
- 3016248538
- 2126677
- 3004962788
- 3009963139
Source Documents#
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| 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 |
Legacy Summary#
summary
FDA Review#
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