Tron 11050

by Xoran Technologies, LLC

Tron 11050 is a Class II device made by Xoran Technologies, LLC, cleared under FDA 510(k) K221230 on 28 Jul 2022 and listed in FDA GUDID since 12 Jan 2023 (UDI-DI 00860008443700), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00860008443700 UDI-DI	Date12 Jan 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK221230	Date28 Jul 2022Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00860008443700
FDA 510(k) database 510(k) number K221230

Across registries

2 registries list this device

FDA 510(k) K221230 decided 28 Jul 2022 Active
FDA GUDID UDI-DI 00860008443700 listed 12 Jan 2023 Listed

Timeline

2 dated events

28 Jul 2022 Cleared FDA 510(k) K221230
12 Jan 2023 Listed FDA GUDID 00860008443700

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Tron
Generic name: Mobile general-purpose fluoroscopic x-ray system, digital
Model / reference: 11050

Primary DI / UDI-DI: 00860008443700
510(k) Number: K221230
FDA product code: OWB
GMDN term: Mobile general-purpose fluoroscopic x-ray system, digital

Device class: Class II
Regulation number: 892.1650
GUDID distribution status: In Commercial Distribution

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Other devices filed under Mobile general-purpose fluoroscopic x-ray system, digital.

Other devices from Xoran Technologies, LLC

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Properties

Serial number
Manufacturing date

Other properties (13, all answered No)