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Cti Pet Systems, Inc.

United StatesFDA 510(k) applicant, unverified

Devices
19
FDA recalls
4

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA recalls

What Cti Pet Systems, Inc. makes

Cti Pet Systems, Inc. manufactures positron emission tomography (PET) scanners and PET/CT imaging systems, including models such as the ECAT HRRT, ECAT ACCEL PET SCANNER, LSO PET/CT HIREZ series, and E.CAM LSO 311 PET/SPECT SYSTEM.

The company's devices are classified as Class II and listed in the FDA 510(k) registry. Cti Pet Systems, Inc. is based in the US.

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

Catalogue19

Newest first, rows 1-19 of 19

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Rows 1-19 of 19

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 Cti Pet Systems, Inc., the earliest on 2003-03-04 and the most recent on 2005-04-05. By recorded status: 4 terminated. The reasons filed fall into these groups: mechanical integrity. 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.

  • 2005

    • 5 Apr 2005 Z-0819-05 Unclassified (pre-2012) Terminated Failure to properly secure the Mobile Bed Supports during transit could cause the support screws on the Patient Handling System to become loose and possibly break due to increased vibration during transit. Distribution: Nationwide, Canada, the Netherlands, Ireland & Denmark Submission numbers: K002584, K003241, K962797

  • 2004

    • 27 May 2004 Z-0547-05 Unclassified (pre-2012) Terminated Misalignment of CT and PET scans from performing additional CT scans may produce an incorrect fused data set. In performing additional CT scans, the original PET and CT scans may become misaligned and produce an incorrect fused data set. Distribution: Nationwide, Germany, Spain, Italy, Korea and Canada Submission numbers: K002715, K013504, K023518, K033431, K042467

  • 2003

    • 2 Oct 2003 Z-0106-04 Unclassified (pre-2012) Terminated CPS has found that in some instances, when the CT E-Stop is activated, a malfunction may occur where the PHS controller may not shut down and stop bed motion. Distribution: Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France,…
      Full distribution text Nationwide International: Japan, Germany, Brazil, Spain, China, Russia, Austrailia, Hong Kong, Singapore, Poland France, Korea, Greece, UK and Austria
      Submission numbers: K013504, K002715
    • 4 Mar 2003 Z-0674-03 Unclassified (pre-2012) Terminated Incorrect patient information is displayed in the reconstructed images of a whole body patient scan. Distribution: Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland…
      Full distribution text Nationwide and the following foreign countries: Portugal, Japan Italy, belium, Taiwan, UK, Germany Canada Switzerland Netherlands, Austria, France, Turkey, Spain, Sweden, Korea, Saudi Arabia, Russia, PROC (China), Czech Republic, Denmark, Mexico, Slovakia, and Chile
      Submission numbers: K913637, K920624, K940478, K962797, K002584

Frequently asked questions

How many devices does Cti Pet Systems, Inc. have in the registry?

The registry currently lists 19 devices for Cti Pet Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cti Pet Systems, Inc.'s devices?

Among its 19 most recently registered devices, Cti Pet Systems, Inc. has devices listed in FDA 510(k) (19 devices).

What risk classes do Cti Pet Systems, Inc.'s devices fall under?

Among its 19 most recently registered devices, the classes recorded for Cti Pet Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Cti Pet Systems, Inc.?

FDA recall records list 4 recalls initiated by Cti Pet Systems, Inc., the most recent initiated on 2005-04-05. 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 Cti Pet Systems, Inc. in the registry?

The most recently registered devices listed for Cti Pet Systems, Inc. include ECAT HRRT, ECAT ACCEL PET SCANNER, LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ and LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I.

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