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MobileDiagnost wDR 2.2

by Sedecal., Sa.

510(k) K191813

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

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 · Special NumberK191813 Date2 Aug 2019ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-0276-2026 FDA Class II initiated 10 Jun 2025
    • Ongoing Z-0243-2026 FDA Class II initiated 10 Jun 2025

    Sedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.

    • Ongoing Z-2045-2023 FDA Class II initiated 23 May 2023

    There is a software login in issue that may prevent the user from logging in.

    • Ongoing Z-1083-2024 FDA Class II initiated 14 Oct 2021

    While cleaning or disinfecting the system, if the process is not followed as described in the manual and excessive liquid is used or sprayed directly on the system, it could cause a short circuit of the fine positioning control button. This would result in the system moving on its own in a very slow speed forward circular motion.

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  • Withdrawn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
IZL
Device Class
Class II
Regulation
21 CFR Part 892.1720
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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