AccessGUDID - DEVICE: Optima (00840682115339)

GUDID

Device Identifier (DI) Information

Brand Name: Optima
Version or Model: XR646
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GE Hualun Medical Systems Co., Ltd

Primary DI Number: 00840682115339
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554408665 *Terms of Use

Device Description: XR646 SYS Cabinet UDI

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37645	Stationary basic diagnostic x-ray system, digital	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQB	Solid state x-ray imager (flat panel/digital imager)
KPR	System, x-ray, stationary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K143270	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4ca97eb0-27e6-42a7-a9e3-bcf36ce81c62
Public Version Date: April 07, 2025
Public Version Number: 4
DI Record Publish Date: June 01, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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