Althea US, Inc.

FDA Device Registration & Listing · Goodlettsville, TN, US · Registration 3007603422

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
3007603422
FEI Number
3007603422
Entity Name
Althea US, Inc.
City/State/Country
Goodlettsville, TN, US
Establishment Address
101 Old Stone Bridge, Goodlettsville, TN 37072, US
Establishment Type(s)
Repack or Relabel Medical Device
Owner / Operator
Althea US (Owner Number: 10046418)
Owner / Operator Contact Address
101 Old Stone Bridge, Goodlettsville, TN 37072, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

GE Philips Siemens

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IZO Generator, High-Voltage, X-Ray, Diagnostic Radiology Class 1 892.1700 2023-03-26

Official Correspondent

Michael Gossman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Althea US
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
K950291 Fischer Imaging Corp. DIGITAL 625HF 1995-03-23

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007603422. Last updated year: 2026. Please use registration number 3007603422 when referencing this establishment in official correspondence.
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