Data / Medical devices / Chile / Digit Systems SPA
Digit Systems SPA: FDA-registered device maker in Santiago Region Metropolitana, Chile, 1 510(k) clearance
Digit Systems SPA is registered with the FDA (registration 3030210400) in Santiago Region Metropolitana, Chile. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated March 21, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030210400
- Address
- Victoria 427, San Bernardo, Santiago Region Metropolitana, Chile, 8071064
- Owner or operator
- Digit Systems SpA (10094992)
- Roles
- Exporter to the US
- First device listed
- January 13, 2026
- Registered through
- 2026
- Brand names listed
- GE Discovery 710 PET/CT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Tomography, Computed, Emission | KPS | 2 | 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 |
|---|---|---|---|---|---|---|
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
Compare with other makers
Updated March 21, 2014. 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.