510(k) K233714
- Device
- BreView
- Applicant
- GE Medical Systems SCS
- 510(k) number
- K233714
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-25
- Date received
- 2023-11-20
- Regulation
- 892.2050
- Classification name
- System, Image Processing, Radiological
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Indu Karun
- Address
- 283 Rue De La Miniere 78530 Buc Buc FR 78530 78530
FDA Registration Numbers#
- 3033527241
- 3007120336
- 3011213614
- 3011501361
- 1000314502
- 3008481104
- 3030228551
- 3019544554
- 3014954414
- 3033527273
- 3000190675
- 1125622
- 3038187462
- 3008596921
- 3011240766
- 3012916784
- 3004485675
- 3013844297
- 3011114764
- 3010287737
- 3007545404
- 3021637148
- 3010342382
- 3008110533
- 3010533307
- 1047843
- 8030128
- 2936485
- 3024820186
- 3009302839
- 3009196578
- 3024040179
- 1043653
- 3015537315
- 3009185973
- 3019006180
- 1644408
- 3001675293
- 3043840131
- 3004497354
- 3042175844
- 3013041594
- 2031966
- 1032347
- 3000976525
- 3027408258
- 9680215
- 3014132130
- 9610482
- 3003769120
- 3015276088
- 3003998208
- 3008012314
- 3005778458
- 3017991646
- 3029915548
- 3010160527
- 3033527770
- 3014232555
- 3030979155
- 3009140718
- 3001722928
- 3005406110
- 9613347
- 3008142630
- 3024185724
- 3005914761
- 9617978
- 3011307657
- 3012075008
- 3005517190
- 3011221522
- 3010197287
- 3030228575
- 3002619337
- 3009149931
- 3023266032
- 3024438491
- 3004120479
Source Documents#
Other 510(k) Records For Product Code LLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253831 | CMN Capillary Function with Virtual Expert for MRI, CT and CBCT | Cercare Medical A/S | 2026-05-18 |
| K254013 | SubtleHD-PET (1.x) | Subtle Medical, Inc. | 2026-05-14 |
| K260321 | HipGuide (V 1.0.0.0) | Orthopedic Driven Imaging, LLC | 2026-05-08 |
| K260716 | Neowise | Cefla S.C. | 2026-05-04 |
| K260009 | LungPoint Virtual Bronchoscopic Navigation (VBN) Software | Broncus Medical, Inc. | 2026-04-24 |
| K254237 | CCI PACS VIEWER (PACS-US-001) | CliniComp, Intl. | 2026-04-23 |
| K253029 | RW-1 | Mediott, Inc. | 2026-03-31 |
| K253950 | Avatar Medical Vision | Avatar Medical | 2026-03-30 |
| K252195 | ARTICOR planner | Artiness S.R.L | 2026-03-27 |
| K260479 | TheraSphere 360™ Y-90 Management Platform | Boston Scientific Corporation | 2026-03-13 |
| K253111 | Aeka Imaging | Good Methods Global, Inc. | 2026-03-13 |
| K251964 | Mimics Thoracic Planner | Materialise NV | 2026-03-12 |
| K253486 | SKIA-Head (Model: SKIA-ST00) | Skia, Inc. | 2026-02-23 |
| K260205 | AS Software Version Asera | AS Software, LLC | 2026-02-19 |
| K253927 | LiveMedica Enterprise PACS | Live Medica, LLC | 2026-02-06 |