HC150 - 1.5T Head Coil Upper Assy

GUDID 00857534006400

Upper Assembly, 1.5T IOHv2 (Es/SAE), 110812-600

DEERFIELD IMAGING, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00857534006400
• NIH Device Record Key: b0528ca1-270e-479e-8d5b-09a68f423534
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HC150 - 1.5T Head Coil Upper Assy
• Version Model Number: HC150 Upper Assy
• Company DUNS: 079990922
• Company Name: DEERFIELD IMAGING, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00857534006400 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103506

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-02-28

On-Brand Devices [HC150 - 1.5T Head Coil Upper Assy]

• 00857534006400: Upper Assembly, 1.5T IOHv2 (Es/SAE), 110812-600
• 00857534006257: Upper Assembly, 1.5T IOHv2 (Es/SAE), 110812-000