FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Synapse Enterprise Viewer Version 1.0
K Number: K183248
·
Decision Apr 25, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
41
Review Days
155
Basic Information
- Device Name
- Synapse Enterprise Viewer Version 1.0
- K Number
- K183248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Corporation
- Date Received
- November 21, 2018
- Decision Date
- April 25, 2019
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by FUJIFILM Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K244017 | FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000 | Jun 13, 2025 | Substantially Equivalent |
| K243512 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Jun 10, 2025 | Substantially Equivalent |
| K243762 | Synapse 3D Base Tools (V7.0) | May 21, 2025 | Substantially Equivalent |
| K250370 | SCENARIA View Phase 5.0 | May 20, 2025 | Substantially Equivalent |
| K230751 | EW10-EC02 Endoscopy Support Program | Dec 15, 2023 | Substantially Equivalent |
| K223827 | FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 | Sep 8, 2023 | Substantially Equivalent |
| K221677 | Synapse 3D Base Tools v6.6 | Nov 10, 2022 | Substantially Equivalent |
| K221238 | FUJIFILM Ultrasonic Endoscope EG-740UT | Aug 19, 2022 | Substantially Equivalent |
| K221952 | Endoscope Model EG-580UT and Endoscope Model EG-580UR | Aug 4, 2022 | Substantially Equivalent |
| K212873 | Aspire Cristalle | May 27, 2022 | Substantially Equivalent |