FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synapse Cardiovascular
K Number: K151859
·
Decision Aug 12, 2015
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
20
Review Days
35
Basic Information
- Device Name
- Synapse Cardiovascular
- K Number
- K151859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
- Date Received
- July 8, 2015
- Decision Date
- August 12, 2015
- 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 MEDICAL SYSTEMS U.S.A., INC.
| K Number | Device Name | ||
|---|---|---|---|
| K152257 | Fujifilm Duodenoscope Model ED-530XT | Jul 21, 2017 | Substantially Equivalent |
| K162287 | Synapse 3D Perfusion Analysis | Apr 6, 2017 | Substantially Equivalent |
| K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter) | Jun 29, 2016 | Substantially Equivalent |
| K153464 | FDR D-EVO flat Panel Detector System | Apr 8, 2016 | Substantially Equivalent |
| K160108 | Synapse PACS | Feb 3, 2016 | Substantially Equivalent |
| K153483 | Balloon controller PB-30 | Dec 15, 2015 | Substantially Equivalent |
| K143556 | Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T | Aug 20, 2015 | Substantially Equivalent |
| K141765 | FDR D-EVO FLAT PANEL DETECTOR SYSTEM | Oct 3, 2014 | Substantially Equivalent |
| K140149 | EPX-4440HD DIGITAL VIDEO PROCESSOR | Aug 22, 2014 | Substantially Equivalent |
| K132210 | FUJIFILM 600 SERIES ENDOSCOPES | Jan 10, 2014 | Substantially Equivalent |