MEDSOURCE PARTS, LLC

FDA Device Registration & Listing · Boulder, CO, US · Registration 3019373577

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3019373577
FEI Number
3019373577
Entity Name
MEDSOURCE PARTS, LLC
City/State/Country
Boulder, CO, US
Establishment Address
440 Juniper Ave, Boulder, CO 80304, US
Establishment Type(s)
Remanufacture Medical Device
Owner / Operator
MedSource Parts, LLC (Owner Number: 10091617)
Owner / Operator Contact Address
440 Juniper Ave, Boulder, CO 80304, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K023398
PMA Number
N/A

All Registered Proprietary Names

Hologic Selenia Dimensions Hologic Horizon

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2024-11-06
KGI Densitometer, Bone Radiology Class 2 892.1170 2025-08-14

Official Correspondent

Troy Kamphuis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MedSource Parts, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K983273 Medical Systems, Inc. XCT 2000 L PQCT BONE DENSITOMETER 1998-10-29

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-2219-2025 FUJIFILM Healthcare Americas Corporation 3
ASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE Cristalle Digital Breast Tomosynthesis (DBT) Option (approved under P160031).

Similar Registrations

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3040678329 PRIMEX MEDICAL PTY LTD Wembley Western Australia, AU
3008496839 EvERX PTY LTD Sydney New South Wales, AU
3003775006 FUJIFILM Healthcare Manufacturing Corporation Hanamaki Office HANAMAKI-SHI Iwate, JP
3012127758 Siemens Healthcare Limited Oakville Ontario, CA
3013875850 M-SOLUTIONS INC. Tokyo, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019373577. Last updated year: 2026. Please use registration number 3019373577 when referencing this establishment in official correspondence.
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