510(k) K131773
- Device
- BRILLIANCE ICT
- Applicant
- PHILIPS HEALTHCARE (CLEVELAND)
- 510(k) number
- K131773
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-09-24
- Date received
- 2013-06-17
- 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
- CATHERINE M CONNELL
- Address
- 595 Miner Rd. Cleveland OH US 44143 44143
FDA Registration Numbers#
- 3011802799
- 3003768277
- 3015232217
- 3011786147
- 3005930550
- 3015223550
- 3015169361
- 9612283
- 3006487372
- 3003678543
- 3011396687
- 9613445
- 2011171
- 3012085143
- 3006621332
- 9611343
- 1811755
- 3000126629
- 3012127758
- 3023140882
- 3003094912
- 3017425975
- 1054713
- 3003477135
- 3043512431
- 9613299
- 3013679558
- 3006894636
- 3036666444
- 3026970882
- 3017426576
- 2030624
- 2134213
- 3021059265
- 3008769756
- 3004938766
- 2126677
- 3014343100
- 3007562060
- 3004962788
- 3014809646
- 2183744
- 3004083736
- 3017375271
- 3027338963
- 9614698
- 3007225492
- 3001722928
- 3004091527
- 3015537315
- 3023460764
- 3029521953
- 3006209933
- 3014246639
- 3030982377
- 3033524251
- 3019216
- 1066019
- 3002907620
- 3011825597
- 3004198450
- 3007233544
- 3032109181
- 3011050570
- 3008632256
- 3010151377
- 3026391023
- 3012939903
- 3039211310
- 3012453401
- 3008355361
- 3007545404
- 3033527283
- 3014134519
- 3010398867
- 3017210169
- 3015777306
- 2247992
- 3015060224
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K250662 | Bunkerhill MAC | BunkerHill Health | 2025-10-03 |
Legacy Summary#
summary
FDA Review#
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