FDA.reportPublic FDA data

GR10X

Primary DI
08683161912041
Brand
GR10X
Company
XERA TEKNOLOJI VE YAZILIM LIMITED SIRKETI
Model
GR10X-40K
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KPRSystem, X-Ray, Stationary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPRSystem, X-Ray, StationaryRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220149000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220149000General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K)Xera Medical Systems & Technology , Ltd.2022-04-19KPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08683161912041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08683161912041086831619120418683161912041

GMDN Terms#

Term, Definition table
TermDefinition
Computed radiography digital imaging scannerA device/device assembly designed to be used with an analogue x-ray system to capture radiographic images and then generate digital x-ray images from them as part of a two-step process (computed radiography) for image viewing, storage, or hard-copy printing; it is not dedicated to dental use. It consists of an image reader/scanner and may also include an exposure unit with imaging receptor (e.g., a cassette containing a plate), or additional supportive hardware (e.g., a printer). The image is acquired on a photostimulable substance (e.g., a phosphor screen mounted on a cassette plate) and converted into an electrical analogue signal in a laser scanner.

Regulatory Flags#

DUNS number
520097659
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08683161912058GR10XGR10X-50K2026-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08683161912058GR10XXERA TEKNOLOJI VE YAZILIM LIMITED SIRKETIKPR2026-06-22
08908021109004PRORAD 3NCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08908021109011PRORAD 2FCPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDKPR2026-05-07
08809365280001SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
08809365281015SG HealthcareSG Healthcare Co., Ltd.KPR2026-04-24
00198953056103DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00198953056158DefiniumGE Hualun Medical Systems Co., LtdKPR2026-02-12
00195278913807DefiniumGE Hualun Medical Systems Co., LtdKPR2024-10-30
00195278840226DiscoveryGE Hualun Medical Systems Co., LtdKPR2024-07-04
00195278526892DefiniumGE Hualun Medical Systems Co., LtdKPR2023-09-18
00884838110588Precision CRFPhilips Medical Systems DMC GmbHKPR2023-02-14
B216DRH700AC1X-CEL X-RAY CORPORATIONARQUILLA, INC.KPR2022-12-20
04056869951386MULTIX Impact ESiemens Shanghai Medical Equipment Ltd.KPR2022-09-26
00884838103221ProxiDiagnost N90Philips Medical Systems DMC GmbHKPR2022-01-17
04056869279985MULTIX ImpactSiemens Shanghai Medical Equipment Ltd.KPR2021-04-20
04056869262147MULTIX Impact CSiemens Shanghai Medical Equipment Ltd.KPR2021-03-22
08436046003026SEDECALSEDECALKPR2021-02-15
08436046003033SEDECALSEDECALKPR2021-02-15
00195278070265DefiniumGE Hualun Medical Systems Co., LtdKPR2020-11-24
00810035220386Radmedix AcuityFDRRADMEDIX, LLCKPR2020-09-18
00810035220393Radmedix AcuityFDR+RADMEDIX, LLCKPR2020-09-18
00810035220409Radmedix AcuityCDRRADMEDIX, LLCKPR2020-09-18
00810035220416Radmedix AcuitySDRRADMEDIX, LLCKPR2020-09-18
00810035220423Radmedix AcuitySDR+RADMEDIX, LLCKPR2020-09-18
00810030350071uDRUIH TECHNOLOGIES LLCKPR2020-05-26
00810030350002uDRUIH TECHNOLOGIES LLCKPR2020-04-29