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Optima Urs Universal Radiographic System

by Sedecal USA, Inc.

510(k) K012546

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 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 · Traditional NumberK012546 Date2 Nov 2001ClearedStatusActive

Recalls

2 recalls · 1 ongoing · FDA

    • Ongoing Z-0781-2024 FDA Class II initiated 13 Dec 2023

    Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.

    • Terminated Z-0652-03 FDA Unclassified (pre-2012) initiated 24 Sep 2002 on shared 510(k) K012546

    Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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