Duns Number:713686549
Device Description: The Heart3R-110 is Portable X-ray Machine, intended for use by a qualified/trained physici The Heart3R-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.
Catalog Number
-
Brand Name
Yian Medical Technology (Haining) Co., Ltd.
Version/Model Number
Heart3R-110
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K220700
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
c89a8864-2c05-4a1b-9f54-cd1584d455f0
Public Version Date
July 05, 2022
Public Version Number
1
DI Record Publish Date
June 27, 2022
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |