XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.

FDA Device Registration & Listing · Yenimahalle Ankara, TR · Registration 3023190435

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023190435
FEI Number
3023190435
Entity Name
XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.
City/State/Country
Yenimahalle Ankara, TR
Establishment Address
Inonu Mah. 1730.CAD. NO:5/1, Yenimahalle Ankara 06370, TR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
XERA Medikal Sistemleri ve Teknoloji Ltd. Sti. (Owner Number: 10085374)
Owner / Operator Contact Address
Inonu Mah. 1730.CAD. NO:5/1, Yenimahalle, TR-06 06370, TR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

GR10X-40K XERA OCTAVE GR10X-50K

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2022-06-09

Official Correspondent

Hyunsuk Jang

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

XERA Medikal Sistemleri ve Teknoloji Ltd. Sti.
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
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21
K123106 Samsung Electronics Co., Ltd. DIGITAL DIAGNOSTIC X-RAY SYSTEM MODEL XGEO GU60A 2013-06-20
K203340 Siemens Medical Solutions USA, Inc. MULTIX Impact C 2021-01-06
K230241 Sg Healthcare Co, Ltd. Jumong General 2023-02-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2009 GE Medical Systems, LLC 2
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
Z-0002-2015 Siemens Medical Solutions USA, Inc 2
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Z-0003-2009 GE Medical Systems, LLC 2
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 5194381. GE Healthcare, 3000 North Grandview, Waukesha, WI 53188. Intended for use in generating Tomographic images of human anatomy.
Z-0003-2015 Siemens Medical Solutions USA, Inc 2
Siemens AXIOM Luminos dRF Max systems The Axiom Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The Axiom Luminos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image.
Z-0004-2015 Siemens Medical Solutions USA, Inc 2
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for urological, gastroenterological and gynecological treatment, planning and diagnostic procedures including but not limited to: "Querying and retrieving patient history information and/or previous diagnosis and images from other modalities; "X-ray examinations of the urogenital area "Ultrasound examinations "Endourological interventions "Percutaneous interventions "Laparoscopy "Application of fistula "Simple procedures "Extracorporeal shock wave lithotripsy "Uroflow/urodynamics "Pediatric radiological and therapeutic applications

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023190435. Last updated year: 2026. Please use registration number 3023190435 when referencing this establishment in official correspondence.
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