Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021909385

FEI Number

3021909385

Entity Name

X-Ray America, LLC

City/State/Country

Charleston, SC, US

Establishment Address

1944 Belgrade Ave, Charleston, SC 29407, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

X-Ray America, LLC (Owner Number: 10093477)

Owner / Operator Contact Address

1944 Belgrade Ave, Charleston, SC 29407, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

I.A.E. SpA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ITY	Assembly, Tube Housing, X-Ray, Diagnostic	Radiology	Class 1	892.1760	2025-05-22

Official Correspondent

David Hurlock

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

X-Ray America, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

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3006789424	Hangzhou Kailong Medical Instruments Co., Ltd.	Hangzhou Zhejiang, CN
3000275399	Siemens Healthineers AG	RUDOLSTADT Thuringia, DE
3017616637	MINGWEI MEDICAL TECHNOLOGY(SUZHOU) CO.,LTD	Suzhou Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021909385. Last updated year: 2026. Please use registration number 3021909385 when referencing this establishment in official correspondence.