Soteria.AI— 510(k) K212336
Substantially EquivalentOmega Medical Imaging, LLC
FDA 510(k) clearance K212336 for Soteria.AI, Substantially Equivalent on 2021-11-17. Applicant: Omega Medical Imaging, LLC. Device class: 2.
Clearance details
- Applicant
- Omega Medical Imaging, LLC
- Product code
- Code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sanford, FL, US
Recent devices under product code OWB
view allMore clearances from Omega Medical Imaging, LLC
view all- K242488 — Soteria E-View
- K212890 — Nyquist.IQ
- K191713 — CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield (ROI Assembly)
- K182834 — CS-series-FP with Optional ROI Accessory CA-100S
- K171755 — CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System
Adverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.