Skip to content

Soteria Eview GI-100

by Omega Medical Imaging, LLC

Soteria Eview GI-100 is a stationary angiographic x-ray system (FDA Class II; FDA product code JAA, System, X-Ray, Fluoroscopic, Image-Intensified) made by Omega Medical Imaging, LLC, cleared under FDA 510(k) K242488 on 6 Jan 2025 and listed in FDA GUDID since 3 Oct 2025 (UDI-DI 00853901007049), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K242488

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00853901007049 UDI-DI Date3 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK242488 Date6 Jan 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K242488 decided 6 Jan 2025 Active
  • FDA GUDID UDI-DI 00853901007049 listed 3 Oct 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K242488
  2. Listed FDA GUDID 00853901007049

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Soteria Eview
Generic name
Stationary angiographic x-ray system, digital
Model / Ref / Catalog
GI-100
Primary DI / UDI-DI
00853901007049
510(k) Number
FDA product code
JAA
GMDN term
Stationary angiographic x-ray system, digital
Device class
Class II
Regulation number
892.1650
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified).

Other devices from Omega Medical Imaging, LLC

See all devices from Omega Medical Imaging, LLC →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)