Data / Medical devices / Italy / Ralco S.R.L.
Ralco S.R.L.: FDA-registered device maker in Biassono Monza e Brianza, Italy, 6 510(k) clearances
Ralco S.R.L. is registered with the FDA (registration 9680895) in Biassono Monza e Brianza, Italy. It lists 3 device types. The FDA files 6 510(k) clearances under its listings, the newest dated August 10, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9680895
- FEI number
- 3004839934
- Address
- Via Dei Tigli 13G, Biassono Monza e Brianza, Italy, 20853
- Owner or operator
- RALCO S.R.L. (9012196)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 19, 2007
- Registered through
- 2026
- Brand names listed
- P 225 ACS DHHS, P 232 DHHS, P 313/A, R 104 F DHHS, R 104/A, R 108 DHHS, R 108 F DHHS, R 108/237A/F and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Collimator, Automatic, Radiographic | IZW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Collimator, Manual, Radiographic | IZX | 2 | Manufacturer | accessdata.fda.gov |
| Device, Beam Limiting, X-Ray, Diagnostic | KPW | 2 | Contract manufacturer, Manufacturer | 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 |
|---|---|---|---|---|---|---|
| August 10, 2011 | K110856 | RALCO | IZX | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| July 14, 2009 | K091517 | RALCO, MODEL R225 ACS | IZW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| December 5, 2008 | K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | IZW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| November 26, 2007 | K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | IZW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| August 1, 2003 | K030487 | R 72 | KPW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
| May 11, 1995 | K946320 | R 302 | KPW | Substantially Equivalent | Ralco S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Collimator, Manual, Radiographic
- All makers of Collimator, Automatic, Radiographic
- All makers of Device, Beam Limiting, X-Ray, Diagnostic
Updated August 10, 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.