510(k) K151403
- Device
- Positron Emission Tomography (PET) And Computed Tomography (CT) System, Positron Emission Tomography (PET) And Computed Tomography (CT) System
- Applicant
- NEUSOFT MEDICAL SYSTEMS CO., LTD.
- 510(k) number
- K151403
- Product code
- KPS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-11-02
- Date received
- 2015-05-26
- Regulation
- 892.1200
- Classification name
- System, Tomography, Computed, Emission
- 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#
- 3009136051
- 9611343
- 3004754211
- 3026047529
- 3022742930
- 3026391023
- 3014809646
- 9613299
- 3005877899
- 1833124
- 3006209933
- 3005810333
- 2126677
- 3005945241
- 3007675950
- 3015276088
- 1424263
- 3018788582
- 3007545404
- 3004504920
- 3013679558
- 3015425142
- 3015232217
- 3015763655
- 3015777306
- 3010703925
- 3008496839
- 3014343100
- 3035950510
- 8022257
- 8030233
- 3000126629
- 9617978
- 2247992
- 1034973
- 3003477135
- 9614698
- 3032577207
- 1066019
- 3011416394
- 3033524251
- 9613936
- 9710645
- 3010398867
- 3027339477
- 3021059265
- 3008355361
- 3009963139
- 3012690638
- 3009196578
- 9613445
- 3014954414
- 2134213
- 3002808157
- 3030210400
- 3029521953
- 3004993756
- 2411512
- 3014470527
- 3034246184
- 3012085143
- 3016007746
- 3000976525
- 3030186509
- 3011015597
- 3031503890
- 3008962177
- 1450662
- 3027338963
- 1423348
- 3005128583
- 1423253
- 3008632256
- 3012761544
- 2320968
- 3017375271
- 2031050
- 3006611212
- 3030982377
- 3023003446
Source Documents#
Other 510(k) Records For Product Code KPS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261305 | MICSI-PET | Microstructure Imaging, Inc. | 2026-09-11 |
| K261427 | uMI Panvivo (uMI Panvivo M) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-07-28 |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family | Siemens Medical Solutions USA, Inc. | 2026-05-21 |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-04-03 |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES) | Shanghai United Imaging Healthcare Co., Ltd. | 2026-02-13 |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464) | Spectrum Dynamics Medical, Ltd. | 2026-01-13 |
| K253844 | AnyScan 3.0 NM Scanner Family | Mediso Medical Imaging Systems, Ltd. | 2025-12-30 |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21 | Canon Medical Systems Corporation | 2025-12-01 |
| K251401 | PennPET Explorer Positron Emission Tomograph | Trustees of the University of Pennsylvania | 2025-11-25 |
| K252477 | Hybrid Viewer (00859873006240) | Hermes Medical Solutions AB | 2025-09-09 |
| K250170 | PHAROS | Brightonix Imaging | 2025-08-15 |
| K251561 | Biograph Trinion | Siemens Medical Solutions USA, Inc. | 2025-07-31 |
| K251839 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S) | Shanghai United Imaging Healthcare Co., Ltd. | 2025-07-17 |
| K251671 | Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems | Siemens Medical Solutions USA, Inc. | 2025-07-03 |
| K251153 | Aurora | Ge Medical Systems Israel | 2025-06-12 |
Legacy Summary#
summary
FDA Review#
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