FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synapse PACS (7.6.0)
K Number: K261713
·
Decision Jun 18, 2026
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
13
Review Days
27
Basic Information
- Device Name
- Synapse PACS (7.6.0)
- K Number
- K261713
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM Healthcare Americas Corporation
- Date Received
- May 22, 2026
- Decision Date
- June 18, 2026
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QIH), ordered by most recent decision date.
WatchMate Software
FDA 510(k)
FDA Class 2
·Radiology
MediAI-OA
FDA 510(k)
FDA Class 2
·Radiology
LungMaps
FDA 510(k)
FDA Class 2
·Radiology
Brainomix 360 Hyperdensity
FDA 510(k)
FDA Class 2
·Radiology
Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
FDA 510(k)
FDA Class 2
·Radiology
DEEPVESSEL Plaque
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by FUJIFILM Healthcare Americas Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K251204 | FUJIFILM Stiffening Wire Device (SW-2000) | Sep 26, 2025 | Substantially Equivalent |
| K243647 | Synapse PACS (7.5) | Jun 30, 2025 | Substantially Equivalent |
| K233321 | Double Balloon Endoscope EN-840T, Over-tube TS-1214C | Jun 13, 2024 | Substantially Equivalent |
| K233629 | APERTO Lucent MRI System | May 10, 2024 | Substantially Equivalent |
| K233687 | ECHELON Synergy V10.0 | May 3, 2024 | Substantially Equivalent |
| K233583 | FCT iSTREAM Phase 1 | Apr 26, 2024 | Substantially Equivalent |
| K240075 | FUJIFILM Endoscope Model EB-710XT | Feb 7, 2024 | Substantially Equivalent |
| K231666 | Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) | Dec 13, 2023 | Substantially Equivalent |
| K231941 | ARIETTA x10 | Nov 20, 2023 | Substantially Equivalent |
| K231574 | Scenaria View 4.2 | Oct 12, 2023 | Substantially Equivalent |