FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
Synapse 3D Blood Flow Analysis
K Number: K191544
·
Decision Oct 18, 2019
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
14
Review Days
129
Basic Information
- Device Name
- Synapse 3D Blood Flow Analysis
- K Number
- K191544
- 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
- June 11, 2019
- Decision Date
- October 18, 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 | ||
|---|---|---|---|
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM Endoscope Model EC-860S/L | May 23, 2025 | Substantially Equivalent |
| K243260 | FUJIFILM Processor EP-8000; FUJIFILM Endoscope Model EG-860R | Apr 11, 2025 | Substantially Equivalent |
| K243091 | Over-tube (TR-1108A) | Nov 1, 2024 | Substantially Equivalent |
| K242779 | Hood (DH-083ST) | Oct 11, 2024 | Substantially Equivalent |
| K240142 | FUJIFILM Endoscope Model EG-840N; FUJIFILM Endoscope Model EG-840T; FUJIFILM Endoscope Model EG-840TP | Sep 4, 2024 | Substantially Equivalent |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Jun 3, 2022 | Substantially Equivalent |
| K203103 | Synapse 3D, Synapse 3D Base Tools v6.1 | Feb 9, 2021 | Substantially Equivalent |
| K203028 | FUJIFILM Distal End Cap | Oct 30, 2020 | Substantially Equivalent |
| K202130 | FUJIFILM Video Laparoscope | Aug 20, 2020 | Substantially Equivalent |
| K192440 | FDR SE Lite | Nov 1, 2019 | Substantially Equivalent |