Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010034862

FEI Number

3010034862

Entity Name

RaySearch Americas Inc.

City/State/Country

Manhattan, NY, US

Establishment Address

The Empire State Building, 350 Fifth Avenue, Suite 5000, Manhattan, NY 10118, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

RaySearch Laboratories AB (publ) (Owner Number: 10029973)

Owner / Operator Contact Address

Eugeniavaegen 18C, Stockholm, SE-AB 11368, SE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K180379

PMA Number

N/A

All Registered Proprietary Names

RayPlan 10B RayTreat 4B RayStation 10B RayCare 3.1 RayStation RayStation 12A RayStation 2023B RayPlan 12A RayPlan 2023B RayPlan 11B RayStation 11B RayTreat 5A RayStation 11A RayPlan 11A RayPlan 10A RayStation 10A RayStation 9B RayPlan 9B RayStation 8B RayCare 2024A SP1 RayStation

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	2021-07-01
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-08-21
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2025-04-08
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2023-05-09
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2022-05-03
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2021-09-13
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2020-11-02
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2019-09-12
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2025-04-28
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2018-04-26

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RaySearch Laboratories AB (publ)

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007774465	RaySearch Laboratories AB (publ)	Stockholm, SE

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010034862. Last updated year: 2026. Please use registration number 3010034862 when referencing this establishment in official correspondence.