H&ABYZ

FDA Device Registration & Listing · Yongin-si Gyeonggi, KR · Registration 3016674851

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
3016674851
FEI Number
3016674851
Entity Name
H&ABYZ
City/State/Country
Yongin-si Gyeonggi, KR
Establishment Address
2-dong, 41-16 Cheoinseong-ro, Namsa-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118, Republic of Korea, Yongin-si Gyeonggi 17118, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
H&abyz (Owner Number: 10062737)
Owner / Operator Contact Address
2-dong, 41-16 Cheoinseong-ro, Namsa-eup, Cheoin-gu, Yongin-si, Gyeonggi-do, 17118, Republic of Korea, Yongin-si, KR-41 17118, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

GR40CW S4335-WV GR40CW GC85A GM85 A1717MCW A1417MCW F1417MCW S4335-W XGEO GR40CW GR40CW GR40CW S4343-W S3025-W GR40CWC GR40CW GR40CWD GM85 GR40CW HnX-P1 HnX-PB HAD1717MC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-05-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-03-17
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-05-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-03-13
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-05-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-05-01
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2023-05-01
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2023-05-01
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2025-08-05
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2021-12-07
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2020-03-05

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

H&abyz
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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25
K201670 Siemens Medical Solutions USA, Inc. YSIO X.pree 2020-10-21

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016674851. Last updated year: 2026. Please use registration number 3016674851 when referencing this establishment in official correspondence.
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