X-ray Flat Panel Detectors

GUDID 06970597830172

CareRay Digital Medical Technology Co., Ltd.

Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital Portable basic diagnostic x-ray system, digital

• Primary Device ID: 06970597830172
• NIH Device Record Key: 8f6a7485-9aa8-4eaf-a662-c427f6ecee56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: X-ray Flat Panel Detectors
• Version Model Number: CareView 1500Cwe
• Company DUNS: 421333508
• Company Name: CareRay Digital Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970597830172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201932

FDA Product Code

• MQB: Solid State X-Ray Imager (Flat Panel/Digital Imager)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-24
• Device Publish Date: 2020-08-14

Devices Manufactured by CareRay Digital Medical Technology Co., Ltd.

• 06970597831049 - X-ray Flat Panel Detector: 2023-09-12
• 06970597832022 - X-ray Flat Panel Detector: 2023-09-12
• 06970597830752 - X-ray Flat Panel Detector: 2023-02-09
• 06970597830271 - X-ray Flat Panel Detector: 2022-09-05
• 06970597830479 - X-ray Flat Panel Detector: 2021-03-09
• 06970597830172 - X-ray Flat Panel Detectors: 2020-08-24
• 06970597830172 - X-ray Flat Panel Detectors: 2020-08-24
• 06970597830745 - X-ray Flat Panel Detector: 2020-08-24
• 06970597830721 - X-ray Flat Panel Detector: 2019-12-24