Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3023344262

FEI Number

3023344262

Entity Name

EMPYREAN MEDICAL SYSTEMS, INC.

City/State/Country

Boca Raton, FL, US

Establishment Address

3010 N Military Trail #220, Boca Raton, FL 33431, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Empyrean Medical Systems, Inc. (Owner Number: 10085591)

Owner / Operator Contact Address

3010 N Military Trail #220, Boca Raton, FL 33431, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K182641

PMA Number

N/A

All Registered Proprietary Names

TVM Balloon Applicator Morpheus TPS Workstation Morpheus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2022-07-07
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	Class 2	892.5050	2022-07-07
JAD	System, Therapeutic, X-Ray	Radiology	Class 2	892.5900	2022-07-07

Official Correspondent

Kal Fishman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Empyrean Medical Systems, 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
K241174	Carl Zeiss Meditec, AG	INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)	2025-01-10
K993675	Nomos Corp.	PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM	2000-09-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2018	Carl Zeiss Meditec AG Rudolf-Eber-Str. 11 Oberkochen Germany	2	Carl Zeiss INTRABEAM PRS 500, product #304534-0000-500. The firm name on the label is Carl Zeiss Meditec AG, Jena, Germany. The INTRABEAM System is indicated for radiation therapy treatments
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
3036107971	VOXEL RAY SOLUTIONS, LLC	Burr Ridge, IL, US
3032638959	Elekta Inc.	San Jose, CA, US
3015232217	ELEKTA SOLUTIONS AB	STOCKHOLM, SE
3030230020	KOPLAK CORP	Sunrise, FL, US
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023344262. Last updated year: 2026. Please use registration number 3023344262 when referencing this establishment in official correspondence.