Data / Medical devices / Australia / Cis Computerised Imaging Services Pty Ltd
Cis Computerised Imaging Services Pty Ltd: FDA-registered device maker in Bondi Junction New South Wales, Australia, 4 510(k) clearances
Cis Computerised Imaging Services Pty Ltd is registered with the FDA (registration 3010789868) in Bondi Junction New South Wales, Australia. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated July 20, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010789868
- Address
- 3 Waverley Street Suite 406, Level 4, Bondi Junction New South Wales, Australia, 2022
- Owner or operator
- CIS Computerised Imaging Services Pty Ltd (10047067)
- Roles
- Exporter to the US
- First device listed
- June 23, 2014
- Registered through
- 2026
- Brand names listed
- GE BrightSpeed CT, GE LightSpeed VCT CT, GE Optima 660 CT, X-RAY TUBE, X-Ray System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Assembly, Tube Housing, X-Ray, Diagnostic | ITY | 1 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Exporter to the US | accessdata.fda.gov |
| Tube Mount, X-Ray, Diagnostic | IYB | 1 | Exporter to the US | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 1, 2005 | K050297 | SOMATOM EMOTION 16 | JAK | Substantially Equivalent | Siemens Medical Solution, Inc. USA | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of Assembly, Tube Housing, X-Ray, Diagnostic
- All makers of Tube Mount, X-Ray, Diagnostic
Updated July 20, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.