# K012546: Optima Urs Universal Radiographic System

- Pathway: 510(k) (Traditional)
- Applicant: Sedecal USA, Inc.
- Decided: Nov 2, 2001 after 87 days
- Product code: KPR (System, X-Ray, Stationary)
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001201 (2000). 1 ancestor in all.
158 later devices descend from it; 7 cite it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001201: Multix Compact K and Multix L Radiographic X-Ray Systems, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.

## Most influential descendants
- K042876: Urs LP Digital, Millennium, Radpro (2004), 138 descendants of its own
- K062335: Sedecal X Plus LP Plus (2006), 99 descendants of its own
- K090238: Sedecal X-Plus LP Plus Digital Diagnostic X-Ray Systems (2009), 46 descendants of its own
- K082604: Viztek DR, Models: DR1000, DR3000, DR4000 (2008), 41 descendants of its own
- K102123: Vizion DR (2011), 36 descendants of its own

## Recalls of this device
- Dec 13, 2023 · Class II · Z-0781-2024: Some parts have fallen off the equipment resulting in a safety risk to patients and/or users.
- Sep 24, 2002 · Not classified · Z-0652-03: Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards.

## Indications for use
The “Optima URS" Universal Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

Source page: https://510kreport.com/device/K012546
Methodology: https://510kreport.com/methodology