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Sedecal USA, Inc.

United StatesFDA applicant, unverified

Devices
3
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Sedecal USA, Inc. makes

Sedecal USA, Inc. manufactures portable and mobile X-ray units, including the EASY MOVING MOBILITY X-RAY UNIT (SM-HF), the OPTIMA URS universal radiographic system, and digital portable X-ray units like the SP-HF-4.0 D. These devices are designed for flexible imaging in various clinical settings, such as emergency rooms, operating rooms, and mobile care environments.

The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. These devices are listed in the FDA’s 510(k) database, reflecting their regulatory compliance. Sedecal USA, Inc. is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 5 recalls initiated by Sedecal USA, Inc., the earliest on 2002-09-24 and the most recent on 2015-03-23. By recorded status: 5 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2015

    • 23 Mar 2015 Z-1691-2016 Class II Terminated Due to a software defect, the system may sporadically apply the default x ray exposure parameters for an adult ( patient type : Normal ) even though the patient type " Newborn" was selected and is displayed in the generator control area of the Eleva User Interface. Distribution: US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN,…
      Full distribution text US Distribution - TX, OH, NY, MD, IN, PA, DE, WA, NH, AZ, GA, NC, UT, VT, CA, LA, NJ, MN, FL, WI, HI, IA, MA, ME, TN, CT, ID, MI, AR and KS.
      Submission number: K111725

  • 2003

    • 27 Oct 2003 Z-0001-04 Unclassified (pre-2012) Terminated A minimum source-skin-distance of less than 30 cm and not identifying the tube manufacturer on the tube housing label resulted in the SP-HF-4.0 Portable Systems not complying with the U.S. Federal performance standard. Distribution: Vermont Submission number: K020436

  • 2002

    • 26 Sep 2002 Z-0649-03 Unclassified (pre-2012) Terminated Incorrect indentification labels and their certification testing program failed in noncompliance with the U.S. Federal performance standard. Distribution: Nationwide, Mexico, Poland, Japan, Abu Dahbi, Venezuela, Australia, Denmark, Panama, Korea, Columbia, and Africa.
    • 26 Sep 2002 Z-650/51-03 Unclassified (pre-2012) Terminated Incorrect identification labels and failure of the cretification testing resulting in noncompliance with the U.S> Federal performance standard Distribution: North Carolina, Louisiana, New York, New Jersey, Missouri, Kentucky, Texas and Germany Submission number: K012663
    • 24 Sep 2002 Z-0652-03 Unclassified (pre-2012) Terminated Incorrect identification labels and their dertification testing program faialed in noncompliance with U.S. Federal performance standards. Distribution: New York, Texas, Florida and Minnesota. Submission number: K012546

Frequently asked questions

How many devices does Sedecal USA, Inc. have in the registry?

The registry currently lists 3 devices for Sedecal USA, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Sedecal USA, Inc.'s devices?

Among its 3 most recently registered devices, Sedecal USA, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Sedecal USA, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Sedecal USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Sedecal USA, Inc.?

FDA recall records list 5 recalls initiated by Sedecal USA, Inc., the most recent initiated on 23 Mar 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Sedecal USA, Inc. in the registry?

The most recently registered devices listed for Sedecal USA, Inc. include EASY MOVING MOBILE X-RAY UNIT (MODEL SM-HF), OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM and DIGITAL PORTABLE X-RAY UNITS, MODEL SP-HF-4.0 D.

Generated automatically from registry data and not verified by a human reviewer.