FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Soteria E-View
K Number: K242488
·
Decision Jan 6, 2025
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
297
Applicant Total
6
Review Days
138
Basic Information
- Device Name
- Soteria E-View
- K Number
- K242488
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omega Medical Imaging, LLC
- Date Received
- August 21, 2024
- Decision Date
- January 6, 2025
- Product Code
- JAA
- 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 |
|---|---|---|---|
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAA), ordered by most recent decision date.
Adora DRFi (04550010)
FDA 510(k)
FDA Class 2
·Radiology
TRIDENT Mobile Fluoroscopy System
FDA 510(k)
FDA Class 2
·Radiology
ProxiDiagnost N90 / Precision CRF (706110, 706400)
FDA 510(k)
FDA Class 2
·Radiology
CombiDiagnost R90
FDA 510(k)
FDA Class 2
·Radiology
XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5
FDA 510(k)
FDA Class 2
·Radiology
Nautilus
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Omega Medical Imaging, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K212890 | Nyquist.IQ | Dec 13, 2021 | Substantially Equivalent |
| K212336 | Soteria.AI | Nov 17, 2021 | Substantially Equivalent |
| K191713 | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly) | Oct 4, 2019 | Substantially Equivalent |
| K182834 | CS-series-FP with Optional ROI Accessory CA-100S | Mar 29, 2019 | Substantially Equivalent |
| K171755 | CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System | Feb 9, 2018 | Substantially Equivalent |