Stephanix D2RS_B1_N

Stephanix D2RS_B1_N is a Class II device made by Stephanix, cleared under FDA 510(k) K213479 on 23 Dec 2021 and listed in FDA GUDID since 5 Jun 2023 (UDI-DI 03664049000031), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number03664049000031 UDI-DI	Date5 Jun 2023Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK213479	Date23 Dec 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 03664049000031
FDA 510(k) database 510(k) number K213479

Across registries

2 registries list this device

FDA 510(k) K213479 decided 23 Dec 2021 Active
FDA GUDID UDI-DI 03664049000031 listed 5 Jun 2023 Listed

Timeline

2 dated events

23 Dec 2021 Cleared FDA 510(k) K213479
5 Jun 2023 Listed FDA GUDID 03664049000031

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Stephanix
Generic name: Stationary general-purpose fluoroscopic x-ray system, digital
Model / reference: D2RS_B1_N

Primary DI / UDI-DI: 03664049000031
510(k) Number: K213479
FDA product code: JAA, OWB
GMDN term: Stationary 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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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)