Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014873236

FEI Number

3014873236

Entity Name

ADAPTIIV MEDICAL TECHNOLOGIES, INC.

City/State/Country

Halifax Nova Scotia, CA

Establishment Address

1559 Barrington Street, Suite 200-D, Halifax Nova Scotia B3J 1Z8, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Adaptiiv Medical Technologies, Inc. (Owner Number: 10058427)

Owner / Operator Contact Address

1559 Barrington Street, Suite 200-D, Halifax, CA-NS B3J 1Z8, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241318

PMA Number

N/A

All Registered Proprietary Names

Patient-Matched 3D Printed Radiation Therapy Accessory TrueFit Bolus TrueFit Bolus TrueFlex Bolus Nova Surface Applicator

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	2022-06-29
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2026-06-17
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-10-24
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2024-09-03

Official Correspondent

Olga Zhuk

US Agent Details

Robert Morton Business: Quality & Regulatory Services, Inc. Email: bob@qrs-i.com Phone: (925) 7872421

Related Public Records

Same Entity

Adaptiiv Medical Technologies, 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.

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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 3014873236. Last updated year: 2026. Please use registration number 3014873236 when referencing this establishment in official correspondence.