ANKE

GUDID 06950743801058

Magnetic Resonance Imaging System, Model: ASM-050P or OPENMARK 5000

Shenzhen Anke High-Tech Co., Ltd.

Full-body MRI system, permanent magnet

• Primary Device ID: 06950743801058
• NIH Device Record Key: c16c35ae-61de-42f1-8e96-a9abcdceb4e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANKE
• Version Model Number: ASM-050P (OPENMARK 5000)
• Company DUNS: 653717256
• Company Name: Shenzhen Anke High-Tech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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	06950743801058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113281

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-21