1.5T AIR Posterior Array 6015100

GUDID 00198953001998

1.5T AIR Posterior Array

USA INSTRUMENTS, INC.

MRI system coil, radio-frequency

• Primary Device ID: 00198953001998
• NIH Device Record Key: eae29298-09c1-4361-be72-ccc0adcb5e5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1.5T AIR Posterior Array
• Version Model Number: 6015100
• Catalog Number: 6015100
• Company DUNS: 804517571
• Company Name: USA INSTRUMENTS, INC.
• 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: false
• 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	00198953001998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251399

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

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: 2025-12-18
• Device Publish Date: 2025-12-10

Devices Manufactured by USA INSTRUMENTS, INC.

• 00198953001998 - 1.5T AIR Posterior Array: 2025-12-181.5T AIR Posterior Array
• 00198953001998 - 1.5T AIR Posterior Array: 2025-12-18 1.5T AIR Posterior Array
• 00195278665249 - NA: 2023-08-11 48CH HEAD COIL - POSTERIOR
• 00195278575814 - NA: 2023-07-05 3.0T 16ch AIR AA
• 00840682108867 - NA: 2020-03-05
• 00840682114387 - NA: 2020-03-05
• 00840682114394 - NA: 2020-03-05
• 00840682114400 - NA: 2020-03-05
• 00840682114547 - NA: 2020-03-05