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Imaging Sciences International

Also registered as Imaging Sciences International, LLC

Country not established

Devices
3
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Imaging Sciences International makes

Imaging Sciences International manufactures cone beam 3D and 2D panoramic dental imaging systems, including the i-CAT FLX V series and KaVo 3D eXam+ V series. These devices are designed for intraoral and extraoral dental imaging, enabling detailed visualization of teeth, jawbones, and surrounding structures.

The company’s portfolio is regulated under Class II devices in the US and is listed in the FDA’s 510(k) clearance registry. The systems are intended for use in dental diagnostics and are 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 recalls4

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

FDA recall records list 4 recalls initiated by Imaging Sciences International, the earliest on 2009-01-08 and the most recent on 2012-07-30. By recorded status: 4 terminated. The reasons filed fall into these groups: software or firmware, electrical or power and performance or accuracy. 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.

  • 2012

    • 30 Jul 2012 Z-2463-2012 Class II Terminated A condition can occur during renumbering of the patient database using the DEXCopy feature. When renumbering is being performed using the DEXCopy feature and multiple patients with an identical name are present, the software will assign all subsequent records to the first patient record, resulting in mixed patient records. In order for this problem to occur several conditions need to be met: 1) Distribution: Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD,…
      Full distribution text Worldwide Distribution - USA including Washington, DC, AL, AZ, AR, CA, CO, CT, DE, FL, GA, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and the country of Canada.
      Submission number: K090461

  • 2010

    • 15 Dec 2010 Z-3018-2011 Unclassified (pre-2012) Terminated Recalling firm received a customer complaint regarding a defective X-ray tube head and power supply Distribution: X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665,…
      Full distribution text X-ray tube and power supply were distributed to one consignee: Dr. Alan D'Allessandro, 2500 W. Higgins Road, Suite 665, Hoffman Estates, IL 60169
      Submission number: K051980

  • 2009

    • 30 Oct 2009 Z-0543-2010 Unclassified (pre-2012) Terminated overhead carriage drops quickly Distribution: Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany,…
      Full distribution text Worldwide Distribution -- Including the United States, Austria, Australia, Belgium, Brazil, Canada, France, Germany, India, Israel, Italy, Jamaica, Spain, South Korea and Taiwan.
      Submission number: K051980
    • 8 Jan 2009 Z-1265-2009 Unclassified (pre-2012) Terminated faulty calibration Distribution: Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and…
      Full distribution text Worldwide Distribution -- US to states of FL, OH and PA and countries of Canada, Germany, England, Italy and Switzerland.
      Submission number: K061284

Frequently asked questions

How many devices does Imaging Sciences International have in the registry?

The registry currently lists 3 devices for Imaging Sciences International. Devices recorded under merged duplicate company entries are counted once.

Which registries list Imaging Sciences International's devices?

Among its 3 most recently registered devices, Imaging Sciences International has devices listed in FDA 510(k) (3 devices).

What risk classes do Imaging Sciences International's devices fall under?

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

Are there FDA recall records for Imaging Sciences International?

FDA recall records list 4 recalls initiated by Imaging Sciences International, the most recent initiated on 30 Jul 2012. 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 Imaging Sciences International in the registry?

The most recently registered devices listed for Imaging Sciences International include DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC, CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM and i-CAT FLX V series / KaVo 3D eXam+ V series.

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