Data / Medical devices / United States / Medimax-Rsi, LLC
Medimax-Rsi, LLC: FDA-registered device maker in Caguas, PR, United States, 1 510(k) clearance
Medimax-Rsi, LLC is registered with the FDA (registration 3008921184) in Caguas, PR, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated November 8, 2002. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008921184
- Address
- Ave Degetau 4, Bonneville Heights, Caguas, PR, United States, 00725
- Owner or operator
- Medimax-RSI, LLC (10055099)
- Roles
- Repackager or relabeler
- First device listed
- December 19, 2025
- Registered through
- 2026
- Brand names listed
- HOLOGIC DENSITOMETER BONE
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| November 8, 2002 | K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY | KGI | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 8, 2002. 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.