USA INSTRUMENTS, INC.
US Last updated 23 May 2026
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- Devices
- 82
- Registries
- GUDIDFDA 510(k)EUDAMED
- FDA recalls
- 1
Catalogue
3.0T Air Pa Xl 7030100 Ref 7030100
1.5T 12 Channel Body Array Ref K052584
Na 2413107 Ref 2413107
Na 1.5T 8 Channel Ctl Coil Ref 1.5T 8 CHANNEL CTL COIL
Na Cardiac Array 1.5T 5154685 Ref CARDIAC ARRAY 1.5T 5154685
NA 3.0T 16ch AIR AA Ref 3.0T 16ch AIR AA
Na 5432778 Ref 5432778
Na Medial Large Grid Breast Biopsy Plate Ref MEDIAL LARGE GRID BREAST BIOPSY PLATE
Na 1.5T Hd 4 Channel Ctl Coil Ref 1.5T HD 4 CHANNEL CTL COIL
Na 1.5T 4 Channel Ctl Coil Ref 1.5T 4 CHANNEL CTL COIL
NA 3.0T GEM RT Open Array Ref 3.0T GEM RT Open Array
Na 2404877 Ref 2404877
Na Mark 9000 Phased Array Shoulder Coil Ref MARK 9000 PHASED ARRAY SHOULDER COIL
NA 1.5T 8-ch Cardiac Array Ref 1.5T 8-ch Cardiac Array
Na U1-100401 Ref U1-100401
Na U1-100216 Ref U1-100216
NA 1.5T GEM RT Open Array Ref 1.5T GEM RT Open Array
Na Lateral Large Grid Breast Biopsy Plate Ref LATERAL LARGE GRID BREAST BIOPSY PLATE
Na 3.0T Hd Neurovascular Array Ref 3.0T HD NEUROVASCULAR ARRAY
Sharp 9000 Phased Array Brain Coil Ref K994042
Insight 7000 Phased Array Torso Coil Ref K972340
Millennium Iii 4 Channel Neurovascular Coil Ref K032415
Ctl Body / Spine Array Coil Ref K014086
Prima Iii Totalsense Torso Coil Ref K031365
Usa Instruments 3.0T Brain/Spine Array Ref K052916
Spirit Iii Totalsense Cardiac Coil Ref K024187
Power 5000 General Purpose Coil Ref K002483
Millennium 5000 Meurovascular Coil Ref K021141
Mark 9000 Phased Array Shoulder Coil Ref K010946
Millennium Iii 3T-8-Channel Neurovascular Coil Ref K042342
Vision 9000 Phased Array Torso Coil Ref K002482
3T Hd Breast Array Ref K052585
Qd Head Speeder With Speeder NV Attachment Ref K041487
3.0T 8-Channel Ctl Spine Array Ref K042186
3.0T 8 Channel Neurovascular (NV) Array Coil Ref K032618
Premier Iii Phased Array Ctl Spine Coil Ref K030042
Liberty 9000 Breast Coil Ref K000993
Spirit 5000 Cardiac Coil Ref K033490
Mark Iii Phased Array Shoulder Coil Ref K042009
Phased Array Knee And Foot Coil Ref K994040
Interventional Body Coil Ref K000437
Leo 7000 Quadrature Knee Coil Ref K971246
Extremity Coil Ref K013592
Magnetom Symphony Quadrature Tx/Rx Head Coil Ref K021262
Nurvo 9000 Endocavitary Coils Ref K011683
Excalibur 9000 Totalsense Quad Head Array Coil Ref K022582
Alpha 7000 Quadrature Wrist Coil Ref K972205
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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
- US
- DUNS number
- 804517571