510(k) K221677
- Device
- Synapse 3D Base Tools V6.6
- Applicant
- FUJIFILM Corporation
- 510(k) number
- K221677
- Product code
- LLZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-11-10
- Date received
- 2022-06-09
- 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 JP 106-8620 106-8620
FDA Registration Numbers#
- 3026612481
- 3038191646
- 3023266032
- 3017233423
- 3005207094
- 8043933
- 3002579136
- 9613188
- 3009719225
- 3013427569
- 3017585294
- 1644408
- 3030446518
- 3022435840
- 3019878658
- 3009196021
- 3009555440
- 3025394753
- 3025603301
- 3013503781
- 3017545364
- 1054415
- 9611343
- 3017448360
- 1045254
- 1717344
- 3007441485
- 3009756153
- 8022257
- 3013682146
- 3004555721
- 3014232555
- 3005156333
- 3036725840
- 3008487708
- 3006165530
- 3004722076
- 9614587
- 3005202320
- 3030979155
- 3017991646
- 3010684280
- 3019252669
- 3033527770
- 9615992
- 3007457520
- 3004497354
- 3005225421
- 3029877582
- 3015895145
- 9680825
- 3004993756
- 1220246
- 3018302800
- 3006551157
- 3006209933
- 2937707
- 1720929
- 3005450718
- 3013660213
- 3021915828
- 3010377510
- 3006621332
- 1418960
- 1834003
- 3013342228
- 1825014
- 3005718816
- 3001556265
- 3019006180
- 9681475
- 3009156722
- 3030228575
- 1724955
- 3006165260
- 3018133052
- 3005919188
- 3019544554
- 3011213614
Source Documents#
Other 510(k) Records For Product Code LLZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K263648 | Vitrea Advanced Visualization, Version 7.16 | Canon Medical Informatics, Inc. | 2026-10-29 |
| K261763 | MIM – KineticID | Mim Software, Inc. | 2026-10-26 |
| K261531 | PV-iCurve Pro | Perception Vision Medical Technology Co., Ltd. | 2026-10-21 |
| K261788 | Eden PACS | Higia., Inc. d/b/a Eden | 2026-10-21 |
| K263048 | Syngo Carbon Space (VA4) | Siemens Healthineers AG | 2026-09-29 |
| K261874 | Syneris PACS v.1.0.1.0 | Syneris | 2026-09-23 |
| K262442 | HipStudio Analysis | Replasia BV | 2026-09-22 |
| K261855 | Elucid PlaqueIQ | Elucid Bioimaging, Inc. | 2026-09-18 |
| K254214 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | 2026-09-15 |
| K261861 | SPINEsim v1.0 | Mdsim S.A. | 2026-09-15 |
| K262060 | 3D-RD-S | Radiopharmaceutical Imaging & Dosimetry, LLC | 2026-09-04 |
| K261500 | KBA3D (v2.4.0) | S.M.A.I.O | 2026-08-17 |
| K262449 | AdvaView | ADVAHEALTH SOLUTIONS, LLC | 2026-08-14 |
| K261916 | NeuroQuant PET | Cortechs Labs, Inc. | 2026-08-12 |
| K260936 | RadioViewAI | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases