Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030230020

FEI Number

3030230020

Entity Name

KOPLAK CORP

City/State/Country

Sunrise, FL, US

Establishment Address

775 Shotgun Rd, Sunrise, FL 33326, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Koplak Corp (Owner Number: 10089438)

Owner / Operator Contact Address

775 Shotgun Rd, Sunrise, FL 33326, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SRT-100+

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	2023-12-07

Official Correspondent

Mariano Martinez

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Koplak Corp

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

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

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
9615010	CARL ZEISS MEDITEC AG (OBERKOCHEN)	OBERKOCHEN Baden-Wurttemberg, DE
9611894	NUCLETRON B.V.	VEENENDAAL Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030230020. Last updated year: 2026. Please use registration number 3030230020 when referencing this establishment in official correspondence.