USA INSTRUMENTS, INC.
United States(FDA 510(k) applicant) Last updated 23 May 2026
- Devices
- 82
- Registries
- FDA 510(k)
- FDA recalls
- 1
Catalogue
1.5T 16 Channel Brain-Spine Array Coil Ref K052621
Magnetom Trio Quadrature Tx/Rx Head Coil Ref K021330
Gemini Iii Hybrid Tx/Rx 4 Channel Head Coil Ref K033235
Premier Iii Phased Array Ctl Spine Coil Ref K031139
Crystal 5000 Phases Array Tmj Coil Ref K013528
Millennium 9000 Phased Array Neurovascular Coil Ref K001870
Body Array Coil Ref K013594
Open Breast Coil (Obc) With Biopsy Plates Ref K050728
Magna 5000 Phased Array Ctl Spine Coil Ref K994345
Flow 7000 Peripheral Vascular Coil Ref K982339
Premier Iii Phased Array Ctl Spine Coil Ref K013595
Prima Iii Totalsense Torso Coil Ref K030371
Champion 5000 Peripheral Vascular Coil Ref K023247
Shoulder Coil Ref K013541
Mark 5000 Phased Array Shoulder Coil Ref K983143
Alpha 5000 Wrist Coil Ref K031143
Magna 5000 Phased Array Ctl Spine Coil Ref K000002
Premier 7000 Ctl Spine Coil Ref K980157
Hi-Res 9000 Phased Array Carotid Coil Ref K001210
Pelvic Array Coil Ref K033753
Mark 5000 Quadrature Shoulder Coil Ref K013854
Spirit Iii Totalsense Cardiac Coil Ref K031172
Showing 51-82 of 82
FDA recalls
USA Instruments, Inc. has one FDA recall record initiated on March 19, 2004, which is listed with a terminated status. The recall pertains to a defective capacitor in the Body Array Coil, which may cause unstable performance and excessive heating.
2004
- 19 Mar 2004 Z-0849-04 Unclassified (pre-2012) Terminated A defective capacitor in the Body Array Coil may result in unstable, unreliable performance, with excessive heating of patient's body.
What USA INSTRUMENTS, INC. makes
USA Instruments, Inc. manufactures phased array and general-purpose magnetic resonance imaging (MRI) coils for use in diagnostic imaging. These include specialized coils for brain, torso, cardiovascular, shoulder, and spinal applications, designed to enhance MRI signal quality and resolution in specific anatomical regions.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) pathway. These devices are intended for use in MRI systems and are based in the United States.
Frequently asked questions
What types of medical devices does USA Instruments, Inc. manufacture?
USA Instruments, Inc. specializes in manufacturing phased array and general-purpose MRI coils. These coils are designed to improve imaging quality and resolution for specific body regions, such as the brain, torso, cardiovascular system, shoulders, and spine. They are intended for use in MRI systems to enhance diagnostic imaging capabilities.
Where is USA Instruments, Inc. based?
USA Instruments, Inc. is headquartered in the United States. The company’s products are developed and manufactured domestically, ensuring compliance with U.S. regulatory standards for medical imaging devices.
Which regulatory registries or databases list USA Instruments, Inc.’s devices?
USA Instruments, Inc.’s devices are listed in the FDA’s 510(k) registry. This pathway is used for Class II medical devices, which require premarket notification to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
How are USA Instruments, Inc.’s MRI coils classified under U.S. regulations?
USA Instruments, Inc.’s MRI coils are classified as Class II medical devices under FDA regulations. This classification applies to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Why are USA Instruments, Inc.’s coils designed for specific anatomical regions?
The coils are specialized for targeted anatomical regions—such as brain, torso, or neurovascular areas—to optimize MRI signal reception and image clarity. Phased array coils, for example, combine multiple smaller coils to improve coverage and resolution in complex or high-detail areas, while general-purpose coils provide broader imaging flexibility for less specialized scans.
Information
- Country
- United States
- DUNS number
- 804517571