Ge Healthcare Coils (Usa Instruments, Inc.) is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Ge Healthcare Coils (Usa Instruments, Inc.) - FDA 510(k) Cleared Devi...
Recent clearances: 3.0T AIR 32CH HNA, 3.0T 16ch AIR AA, 3.0T Air MP M, 3.0T Air MP L
12
Total
12
Cleared
0
Denied
Ge Healthcare Coils (Usa Instruments, Inc.) has 12 FDA 510(k) cleared radiology devices. Based in Waukesha, US.
Latest FDA clearance: Jan 2026. Active since 2009.
Browse the complete list of FDA 510(k) cleared radiology devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Ge Healthcare Coils (Usa Instruments, Inc.)
12 devices
Cleared
Jan 23, 2026
3.0T AIR 32CH HNA
Radiology
60d
Cleared
Jan 03, 2023
3.0T 16ch AIR AA
Radiology
57d
Cleared
Oct 12, 2018
3.0T Air MP M, 3.0T Air MP L
Radiology
30d
Cleared
Apr 12, 2018
48CH Head Coil
Radiology
29d
Cleared
Nov 22, 2017
AIR Anterior Array, AIR Posterior Array
Radiology
76d
Cleared
Jan 12, 2017
48CH Head Coil
Radiology
58d
Cleared
Mar 06, 2015
3.0T GEM RT Open Array
Radiology
100d
Cleared
Jan 11, 2013
1.5T GEM RT OPEN ARRAY
Radiology
77d
Cleared
Nov 16, 2012
PEDIATRIC POSITIONER PAD SET
Radiology
116d
Cleared
Jan 12, 2011
DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR)
Radiology
56d
Cleared
Jun 23, 2010
8 CHANNEL CARDIAC PHASED ARRAY COIL
Radiology
22d
Cleared
Nov 25, 2009
3.0T 16 CHANNEL HEAD NECK SPINE COIL
Radiology
29d