Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004555507

FEI Number

3004555507

Entity Name

EXTOL, INC

City/State/Country

Zeeland, MI, US

Establishment Address

651 Case Karsten Dr., Zeeland, MI 49464, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Extol, Inc (Owner Number: 10084441)

Owner / Operator Contact Address

651 Case Karsten Dr., Zeeland, MI 49464, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TrueFit Bolus TrueFlex Bolus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-12-17

Official Correspondent

Dan Klompmaker

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Extol, Inc

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
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2012	Elekta, Inc.	2	Dynamic Multileaf Collimator (DMLC) Shapes the radiation beam in treatment therapy.
Z-0038-2017	RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden	2	RayStation 2.5, 3.0, 3.5, 4.0, 4.5, 4.7, 5.0 and 4.3 (InverseArc 1.0) -- Radiation Therapy Treatment Planning System RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

Similar Registrations

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3025309924	SPECTRONIC MEDICAL AB	Helsingborg Skane, SE
3014873236	ADAPTIIV MEDICAL TECHNOLOGIES, INC.	Halifax Nova Scotia, CA
2916710	Varian Medical Systems, Inc	PALO ALTO, CA, US
2030598	Synergy Health AST, LLC	SAN DIEGO, CA, US
3003793371	Varian Medical Systems Finland 0y	Helsinki Uusimaa, FI

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004555507. Last updated year: 2026. Please use registration number 3004555507 when referencing this establishment in official correspondence.