Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025309924

FEI Number

3025309924

Entity Name

SPECTRONIC MEDICAL AB

City/State/Country

Helsingborg Skane, SE

Establishment Address

Karbingatan 36, Helsingborg Skane 25467, SE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Spectronic Medical AB (Owner Number: 10086591)

Owner / Operator Contact Address

Karbingatan 36, Helsingborg, SE-M 25467, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211841

PMA Number

N/A

All Registered Proprietary Names

MRI Planner

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKB	Radiological Image Processing Software For Radiation Therapy	Radiology	Class 2	892.2050	2022-11-22
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2022-11-22

Official Correspondent

Per Bruhn

US Agent Details

Tracey Holevas Business: GE HealthCare Technologies, Inc Email: tracey.holevas@gehealthcare.com Phone: (262) 3092157

Related Public Records

Same Entity

Spectronic Medical AB

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

Registration Number	Establishment Name	Location
3021982861	MEDMIND TECHNOLOGY CO., LTD.	Beijing, CN
3007120336	GE Healthcare Magyarorszag Kft.	Budapest, HU
3022745617	MVISION AI Oy	Helsinki Uusimaa, FI
3002808157	Siemens Healthineers AG	ERLANGEN Bavaria, DE
8043933	BRAINLAB SE	Munich Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025309924. Last updated year: 2026. Please use registration number 3025309924 when referencing this establishment in official correspondence.