Is this your brand? Sign in to claim ownership.

Omega Medical Imaging, LLC

Last updated September 17, 2026

About

AI Image-Guided Interventional Systems that reduce radiation exposure are quickly becoming the new standard of care

From the manufacturer's own website. Source

Device	Model / Reference	Registries	Class	Status
Omega Medical Imaging	CS50	FDA UDI	Class II	Active
Omega Medical Imaging, LLC	Soteria.AI	FDA UDI	Class II	Active
Omega Medical Imaging, LLC	CS-series-FP	FDA UDI	Class II	Active
Nyquist.IQ	IPS-100	FDA UDI	Class II	Active
Soteria E-View	K242488	FDA 510(k)	Class II	Active
Cs-Series-Fp	K100102	FDA 510(k)	Class II	Active
B-400 Ceiling Mounted Possitioner, Model B-400	K990055	FDA 510(k)	Class II	Active
E-View Fluoroscopy System, Model Cs-50	K062647	FDA 510(k)	Class II	Active
Cs-Series Fluoroscopy System, Cs-10 Through Cs-65 (11 Configurations)	K070834	FDA 510(k)	Class II	Active
Nyquist.IQ	K212890	FDA 510(k)	Class II	Active
R605 Facs Collimeter	K050092	FDA 510(k)	Class II	Active
R650 Qdasm Collimator	K093572	FDA 510(k)	Class II	Active
B-350 Ceiling Mounted C-Positioner	K970947	FDA 510(k)	Class II	Active
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly)	K191713	FDA 510(k)	Class II	Active
CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System	K171755	FDA 510(k)	Class II	Active
Model B-200 C-Arm & Model C-300 Cardiac Table	K902005	FDA 510(k)	Class II	Active
CS-series-FP with Optional ROI Accessory CA-100S	K182834	FDA 510(k)	Class II	Active
Soteria.AI	K212336	FDA 510(k)	Class II	Active
Cs-Series-Fp With 3030+option	K121293	FDA 510(k)	Class II	Active

No authorised representatives on record.

Not available yet.

Not available yet.

Not available yet.

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 8, 2023	Z-0160-2024	—	open, classified	An actuator separated from the pivot mechanism on a lower monitor boom system column. The lower boom became detached at the point shown and was restrained by the installed safety cable.
Feb 28, 2023	Z-0156-2024	—	open, classified	An actuator separated from the pivot mechanism on a lower monitor boom system column and became detached and was restrained by the installed safety cable at one location.
Mar 23, 2017	Z-2621-2017	—	terminated	Elevating Monitor Suspension column dropping and will not rise back up.
Jun 21, 2016	Z-2734-2016	—	terminated	Elevating Monitor Suspension separated from the lifting column bracket