FDA.reportPublic FDA data

NA

Primary DI
08806085126855
Brand
NA
Company
Samsung Electronics Co., Ltd.
Model
Grid 3
Device description
Anti-scatter X-ray Grid used as part of Digital X-ray Imaging System that is 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
2016-11-18
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
IXJGrid, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IXJGrid, RadiographicRadiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160997000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160997000GC85ASamsung Electronics Co., Ltd.2016-07-06KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806085126855PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806085126855088060851268558806085126855

Regulatory Flags#

DUNS number
687967554
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806099221355Hearing Aid FeatureV1.02026-10-19
08806099221379Hearing Aid FeatureV1.02026-10-19
08806099222635Hearing Test FeatureV1.02026-10-19
08806099223052Sleep Apnea Feature v2.0v2.X2026-10-19
08806099223069Sleep Apnea Feature v2.0v2.X2026-10-19
08806099236564Sleep Apnea Feature v2.0v2.X2026-10-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589744213199MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-12-19
04589744212628GRID FacileMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744212666MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213069MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
04589744213076MS X-RAY GRIDMITAYA MANUFACTURING CO., LTD.IXJ2025-08-08
00884838125322Grid Landscape for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125339Grid Landscape for SkyPlate large Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125346Grid Portrait for SkyPlate E Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125353Grid Portrait for SkyPlate largePhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125360Grid Portrait for SkyPlate small Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125384Grid Portrait Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125391Grid Landscape Fiber PaxScan4336WPhilips Medical Systems DMC GmbHIXJ2025-06-19
00884838125421X-Ray Grid 40/12/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125438X-Ray Grid 40/12/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125445X-Ray Grid 40/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125452X-Ray Grid 60/10/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125469X-Ray Grid 60/10/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125476X-Ray Grid 60/10/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125483X-Ray Grid 44/8/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125490X-Ray Grid 40/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125506X-Ray Grid 40/8/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125513X-Ray Grid 40/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125520X-Ray Grid 36/8/180 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125537X-Ray Grid 36/8/140Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125544X-Ray Grid 36/8/110Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125551X-Ray Grid 36/12/140 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125568X-Ray Grid 36/12/180Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125575X-Ray Grid 36/12/110 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125582X-Ray Grid 36/12/100 Philips Medical Systems DMC GmbHIXJ2025-06-19
00884838125599X-Ray Grid 44/8/140 Philips Medical Systems DMC GmbHIXJ2025-06-19