FDA.reportPublic FDA data

NA

Primary DI
08806088566313
Brand
NA
Company
Samsung Electronics Co., Ltd.
Model
GU60A
Device description
The GU60A Digital X-ray Imaging Systems are intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2
MQBSolid State X-Ray Imager (Flat Panel/Digital Imager)Radiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806088566313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806088566313088060885663138806088566313

GMDN Terms#

Term, Definition table
TermDefinition
Stationary basic diagnostic x-ray system, digitalAn assembly of devices that comprise general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It uses digital techniques for image capture, display and manipulation. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (a mobile imaging van). This system consists of modular configurations that can be upgraded by the addition of hardware/software components. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.

Regulatory Flags#

DUNS number
687967554
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806092938823ECG Monitor Appv1.12021-08-25
08806094940756Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094940763Samsung ECG Monitor Application with Irregular Heart Rhythm Notificationv1.22023-10-23
08806094948233Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806094948240Samsung ECG App v 1.3 (ECG)v1.32025-06-10
08806090792021ECG Monitor Appv1.12020-09-24
08806090792045ECG Monitor Appv1.12020-09-24
08801643467098NAAuto Lung Nodule Detection2026-03-17
08806088565231NAGC85A2016-09-24
08806088582412NAGM852016-11-26
08806088773797NAGR40CW2019-06-19
08806094936872Samsung Sleep Apnea Feature (Wear OS)1.X2025-02-24
08806094936889Samsung Sleep Apnea Feature (Android OS)1.X2025-02-24
08806092938854Samsung Health Body Composition1.x2021-09-07
08806095896144NAF4343-AW2024-11-26
08806095799636NAGF85-3P2024-10-18
08806095799643NAGF85-SP2024-10-18
08806092938847Samsung Health Body Composition1.x2021-09-07
08806094744934NAF4335-AW2022-10-20
08806094458213NAS4335-AWM2022-05-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854810007007AirDRIcRco, Inc.MQB2026-07-22
00854810007014AirDRIcRco, Inc.MQB2026-07-22
00854810007120iDRIcRco, Inc.MQB2026-07-22
00854810007205AirDRIcRco, Inc.MQB2026-07-22
08809394330906VIVIX-S 4386WVIEWORKS CO., LTD.MQB2026-07-16
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.MQB2026-07-10
08800017000107DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000114DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000121DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08800017000138DRE DuoJPI HEALTHCARE. CO., LTD.KPR2026-07-03
08683161912041GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08057737122040Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08057737122057Villa Sistemi MedicaliVILLA SISTEMI MEDICALI SPAMQB2026-06-04
08055186671089A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLA.T.S. APPLICAZIONE TECNOLOGIE SPECIALI SRLMQB2026-04-02
07899581344695EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581344701EVOLVE SENSORAlliage S/A Indústrias Médico OdontológicaMQB2023-12-08
07899581340253Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340260Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340277Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18
07899581340284Intraoral Dental Digital Imaging SensorAlliage S/A Indústrias Médico OdontológicaMQB2023-10-18