Skip to content

I-Max Pan Ceph Double Sensor 110-120V

by Owandy Radiology

I-Max Pan Ceph Double Sensor 110-120V (9304201011.DS) is a Class II device made by Owandy Radiology, cleared under FDA 510(k) K203374 on 5 Feb 2021 and listed in FDA GUDID since 16 Dec 2021 (UDI-DI 03760262651637), active as of 23 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 23 Oct 2026

Documents

510(k) K203374

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760262651637 UDI-DI Date16 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK203374 Date5 Feb 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203374 decided 5 Feb 2021 Active
  • FDA GUDID UDI-DI 03760262651637 listed 16 Dec 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203374
  2. Listed FDA GUDID 03760262651637

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
I-Max
Generic name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Ref / Catalog
I-MAX PAN CEPH DOUBLE SENSOR 110-120V, 9304201011.DS
Primary DI / UDI-DI
03760262651637
510(k) Number
FDA product code
MUH
GMDN term
Stationary panoramic/tomographic dental x-ray system, digital
Device class
Class II
Regulation number
872.1800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Stationary panoramic/tomographic dental x-ray system, digital

Cleared under the same submission (K203374)

and 5 more cleared under K203374

Similar devices in this category

Other devices filed under Stationary panoramic/tomographic dental x-ray system, digital.

Other devices from Owandy Radiology

See all devices from Owandy Radiology →

Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)