Medical Device Manufacturer · US , Aurora , OH

Usa Instruments, Inc. - FDA 510(k) Cleared Devices

64 submissions · 64 cleared · Since 1997

64

Total

64

Cleared

0

Denied

FDA 510(k) Regulatory Record - Usa Instruments, Inc. Radiology ✕

64 devices

1-12 of 64

Cleared Nov 09, 2005

USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY

Radiology · 23d

Cleared Oct 07, 2005

1.5T 12 CHANNEL BODY ARRAY

Radiology · 17d

Cleared Oct 07, 2005

1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL

Radiology · 14d

Cleared Oct 04, 2005

3T HD BREAST ARRAY

Radiology · 14d

Cleared Jun 28, 2005

OPEN BREAST COIL (OBC) WITH BIOPSY PLATES

Radiology · 99d

Cleared Sep 24, 2004

MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL

Radiology · 25d

Cleared Aug 26, 2004

3.0T 8-CHANNEL CTL SPINE ARRAY

Radiology · 14d

Cleared Aug 26, 2004

11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL

Radiology · 10d

Cleared Aug 11, 2004

MARK III PHASED ARRAY SHOULDER COIL

Radiology · 16d

Cleared Jul 23, 2004

LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE

Radiology · 31d

Cleared Jun 17, 2004

QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT

Radiology · 13d

Cleared Jan 09, 2004

SPIRIT 5000 CARDIAC COIL

Radiology · 66d

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