Yian Medical Technology (Haining) Co., Ltd.

Primary DI
06975023416029
Brand
Yian Medical Technology (Haining) Co., Ltd.
Company
Yian Medical Technology (Haining) Co., Ltd.
Model
Heart5R-110
Device description
The Heart5R-110 is Portable X-ray Machine, intended for use by a qualified/trained physician or technician on adult population for the purpose of acquiring X-ray images of the desired parts of patient’s anatomy (including head, cervical spine, chest, abdomen, lumbar spine, pelvis and extremities).The system is subject to the following limitations of use when stand-mounted:- The device may be used for diagnostic imaging of head, cervical spine, abdomen, lumbar spine, pelvis or extremities.-The device may be used for imaging of the chest when used without a grid.This device is not intended for mammography.
Published
2022-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IZLSystem, X-Ray, Mobile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZLSystem, X-Ray, MobileRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220700000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220700000Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray MachineYian Medical Technology (Haining) Co., Ltd.2022-05-04IZL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975023416029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975023416029069750234160296975023416029

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray system generator, portableAn x-ray generator with special size, weight, and power requirements that makes it suitable for use in a portable x-ray system, e.g., a system intended to be easily disassembled and reassembled at various locations. It is used to regulate incoming voltage and current in order to provide an x-ray tube with the power needed to produce an x-ray beam of the desired voltage (kV) and current (mA). This GMDN code includes transformer and inverter generator designs. Portable x-ray generators typically comprise a control assembly (console) and high voltage transformer assembly or are of a mono-tank generator design.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
713686549
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975023419013Dental Cone-beam Computed TomographyiDT901X12024-01-12
06975023416012Yian Medical Technology (Haining) Co., Ltd.Heart3R-1102022-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800011150129DRGEMDRGEM CorporationIZL2026-05-20
08800011150136DRGEMDRGEM CorporationIZL2026-05-20
07350011170005TrueMobileSolutions For Tomorrow ABIZL2026-05-18
08800184900002X-RAYNEUF Inc.IZL2026-05-11
08800184900019X-RAYNEUF Inc.IZL2026-05-11
08908021109097PRORAD ATLAS ULTRAPORTABLEPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-05-07
08908021109103PRORAD ATLAS ULTRAPORTABLE PLUSPROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITEDIZL2026-04-16
08800040900108Diagnostic X-ray UnitPoskom Co., Ltd.IZL2026-04-15
08800040900221Airbile-100Poskom Co., Ltd.IZL2026-04-15
08800040900245AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900252AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900269AirRay-miniPoskom Co., Ltd.IZL2026-04-15
08800040900276AirRay-miniPoskom Co., Ltd.IZL2026-04-15
00850079606043MC2 Portable X-ray SystemOXOS Medical, Inc.IZL2026-03-25
00850079606050EmitterOXOS Medical, Inc.IZL2026-03-25
04547410571134FDR AQROFUJIFILM CORPORATIONIZL2026-03-20
00858340006479Del Medical, Inc.Del Medical, Inc.IZL2026-03-05
08800060100229REMEX Xcam6REMEDI CO.,LTD.IZL2026-01-22
04056869297309MOBILETT ImpactSiemens Healthcare GmbHIZL2025-11-20
08800011150105DRGEMDRGEM CorporationIZL2025-08-26
08800011150112DRGEMDRGEM CorporationIZL2025-08-26
08800070400074HnX-P1H&abyz Co., LtdIZL2025-08-12
08800070400166HnX-PBH&abyz Co., LtdIZL2025-08-12
08436046003651SEDECALSEDECALIZL2025-03-21
08436046003668SEDECALSEDECALIZL2025-03-21
08436046003675SEDECALSEDECALIZL2025-03-21
08436046003682SEDECALSEDECALIZL2025-03-21
08436046003699SEDECALSEDECALIZL2025-03-21
08436046003705SEDECALSEDECALIZL2025-03-21
08436046003712SEDECALSEDECALIZL2025-03-21