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D2RF Digital Dynamic Remote System

by Stephanix Radiological Systems

510(k) K102529

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK102529 Date7 Oct 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0557-2019 FDA Class II initiated 2 Nov 2018

    The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OWB
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent