510(k) K203103
- Device
- Synapse 3D, Synapse 3D Base Tools v6.1
- Applicant
- Fujifilm Corporation
- 510(k) number
- K203103
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-09
- Date received
- 2020-10-14
- 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
- Randy Vader
- Address
- 26-30, Nishiazabu 2-Chome Minato-Ku Tokyo JP 106-8620 106-8620
FDA Registration Numbers#
- 3014833795
- 9616251
- 1317307
- 3019834893
- 9610905
- 3021635140
- 3018733944
- 3025603301
- 3011545155
- 3016090213
- 9681475
- 3015383864
- 3013464458
- 3008008144
- 3033524690
- 1047843
- 3014665798
- 3007157255
- 3012391689
- 3009293341
- 3016727312
- 2032350
- 3026309987
- 3036758981
- 3010533307
- 2954921
- 3004537781
- 3008027912
- 3021163566
- 3011790297
- 3014343888
- 3006013411
- 9614698
- 3043840131
- 3001722928
- 1064588
- 3015537315
- 3016954909
- 8041160
- 3009758186
- 3034604691
- 3005496266
- 2126677
- 3015231789
- 3010445368
- 3006330030
- 9710602
- 3006209933
- 3005914761
- 2184007
- 3019674997
- 1066019
- 3013342228
- 9615916
- 1000432246
- 3013660213
- 3010132318
- 1836549
- 3015763655
- 3015961056
- 3009341091
- 3030446518
- 3027408258
- 3023702877
- 3007457520
- 3012075008
- 3005945241
- 3021551875
- 3010342382
- 3036756245
- 1226544
- 3017167291
- 3025394753
- 3007734888
- 3003477135
- 3016110967
- 3005156333
- 3009238185
- 3006579682
Source Documents#
Other 510(k) Records For Product Code LLZ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262120 | Avara Viewer | Avara Software | 2026-07-10 |
| K253899 | 3D-Anywhere | Provect.AI | 2026-07-09 |
| K261465 | INDIRA CLOUD VIEWER | INDIGO TECHNOLOGIES | 2026-07-06 |
| K260576 | MeVis AVM Contour | MeVis Medical Solutions AG | 2026-06-30 |
| K260231 | MiPACS V5 (1.0.0) | Apryse Software Corp | 2026-06-25 |
| K253421 | Perfusion Measurement Platform v1 | Quantified Imaging Limited | 2026-06-22 |
| K261352 | 2D Hip Planning Software | One Ortho | 2026-06-08 |
| K260116 | CustoMED Viewer | CustoMED , Ltd. | 2026-06-03 |
| K254265 | Helion Viewer Suite | Videomed Srl ( a Baxter Healthcare Corp company) | 2026-05-27 |
| 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 |