Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008921184

FEI Number

3008921184

Entity Name

MEDIMAX-RSI, LLC

City/State/Country

Caguas, PR, US

Establishment Address

Ave Degetau 4, Bonneville Heights, Caguas, PR 00725, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Medimax-RSI, LLC (Owner Number: 10055099)

Owner / Operator Contact Address

P.O. BOX 9207, Caguas, PR 00725, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K023398

PMA Number

N/A

All Registered Proprietary Names

HOLOGIC DENSITOMETER BONE

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KGI	Densitometer, Bone	Radiology	Class 2	892.1170	2025-12-19

Official Correspondent

DIMARIE MERCED OTERO

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medimax-RSI, 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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008921184. Last updated year: 2026. Please use registration number 3008921184 when referencing this establishment in official correspondence.