510(k) K151383
- Device
- NeuViz 128 Multi-slice CT Scanner System
- Applicant
- NEUSOFT MEDICAL SYSTEMS CO., LTD.
- 510(k) number
- K151383
- Product code
- JAK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-04
- Date received
- 2015-05-22
- 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
- TIAN YUEHUI
- Address
- # 16, Shiji Rd. Hunnan Industrial Area Shenyang CN 110179 110179
FDA Registration Numbers#
- 1226188
- 3002808157
- 3010281549
- 3010326005
- 3011950073
- 3018423337
- 8043933
- 3003575350
- 9612283
- 3026391023
- 3016007746
- 3012761544
- 3017894900
- 3012044688
- 3010151377
- 3012127758
- 3004962788
- 2520313
- 3016965352
- 3007233544
- 3012957335
- 2126677
- 3031503890
- 3008632256
- 3014809646
- 3017425975
- 3011015597
- 3008284470
- 3027373189
- 3023003446
- 1423253
- 2011171
- 3010703925
- 1066019
- 3026047529
- 3033527283
- 1054713
- 3002807636
- 3012085143
- 3029521953
- 3014343100
- 3006610845
- 3036666444
- 3035950510
- 3023460764
- 2134850
- 3003768277
- 3011642792
- 3001722928
- 3010601176
- 3026970882
- 9613445
- 3011802799
- 3014653800
- 3007225492
- 3016619943
- 3008769756
- 3003202425
- 3033527282
- 3004938766
- 3009154005
- 3006487372
- 3003678543
- 3011396687
- 3006894636
- 3015169361
- 3010123525
- 3004857110
- 3004198450
- 3042172882
- 3023140882
- 3011786147
- 2134213
- 3017426576
- 3030982377
- 3011416394
- 3021059265
- 3043512431
- 8022257
Source Documents#
Other 510(k) Records For Product Code JAK #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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 |
| K260167 | Bunkerhill Contrast AVC | BunkerHill Health | 2026-03-06 |
| K260169 | AV Cardiac CT | Philips Medical Systems Nederland B.V. | 2026-03-05 |
Legacy Summary#
summary
FDA Review#
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