Data / Medical devices / United States / Medsource Parts, LLC
Medsource Parts, LLC: FDA-registered device maker in Boulder, CO, United States, 1 510(k) clearance and 1 PMA approval
Medsource Parts, LLC is registered with the FDA (registration 3019373577) in Boulder, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated February 11, 2011. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3019373577
- Address
- 440 Juniper Ave, Boulder, CO, United States, 80304
- Owner or operator
- MedSource Parts, LLC (10091617)
- Roles
- Remanufacturer
- First device listed
- November 6, 2024
- Registered through
- 2026
- Brand names listed
- Hologic Horizon, Hologic Selenia Dimensions
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Densitometer, Bone | KGI | 2 | Remanufacturer | accessdata.fda.gov |
| Digital Breast Tomosynthesis | OTE | 3 | Remanufacturer | 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 |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
Compare with other makers
Updated November 24, 2025. 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.