FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
8641–8664 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 29, 2003
SPIRIT III TOTALSENSE CARDIAC COIL
K031172 · MOS
Usa Instruments, Inc.
Radiology · 45d
Cleared May 23, 2003
FYRELINK VL
K030728 · LLZ
Mpacs, LLC
Radiology · 77d
Cleared May 23, 2003
ULTRAEKOGEL MODELS EK 2000 & EK 2001
K030889 · MUI
Inmed Ltda.
Radiology · 63d
Cleared May 23, 2003
GE 1.5T 8 CHANNEL TORSO COIL
K031209 · MOS
Ge Medical Systems, Inc.
Radiology · 36d
Cleared May 22, 2003
AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7
K031469 · JAK
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared May 21, 2003
VARISEED 7.1
K030534 · KXK
Varian Medical Systems
Radiology · 90d
Cleared May 21, 2003
RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM
K030544 · OWB
Sigma Vision, Inc.
Radiology · 90d
Cleared May 21, 2003
MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...
K030558 · JAQ
Proxima Therapeutics, Inc.
Radiology · 89d
Cleared May 21, 2003
RADIOMED SOFT TISSUE MARKER
K031206 · JAK
Radiomed Corp.
Radiology · 35d
Cleared May 21, 2003
CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G
K031447 · MQB
Canon, Inc.
Radiology · 14d
Cleared May 20, 2003
SR-130
K030494 · IZL
Source-Ray, Inc.
Radiology · 90d
Cleared May 20, 2003
AMERITEK SURE-POINT TRACKER SYSTEM
K030518 · ITX
Amertek Medical, Inc.
Radiology · 90d
Cleared May 13, 2003
PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
K031333 · IZI
Philips Medical Systems North...
Radiology · 15d
Cleared May 13, 2003
ADVANTAGE WORKSTATION PASTING 1.1
K031396 · LNH
GE Medical Systems
Radiology · 11d
Cleared May 09, 2003
ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8
K031347 · ODG
Olympus Optical Co., Ltd.
Radiology · 10d
Cleared May 09, 2003
TRANSVAGINAL DOPPLER PROBE
K031358 · ITX
Vascular Control Systems, Inc.
Radiology · 9d
Cleared May 08, 2003
HEADFIX
K030439 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 86d
Cleared May 08, 2003
MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL
K031056 · MOS
Usa Instruments, Inc.
Radiology · 35d
Cleared May 08, 2003
GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY
K031089 · MOS
W.L. Gore & Associates, Inc.
Radiology · 31d
Cleared May 06, 2003
READI-LOAD SYSTEM, MODEL PSS 1820RL
K022389 · KXK
Worldwide Medical Technologies, LLC
Radiology · 287d
Cleared May 06, 2003
CT COLONOGRAPHY
K023943 · JAK
Ge Medical Systems, Inc.
Radiology · 161d
Cleared May 06, 2003
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH
K030450 · JAK
J. Morita USA, Inc.
Radiology · 84d
Cleared May 06, 2003
CARD EP
K031261 · JAK
GE Medical Systems
Radiology · 15d
Cleared May 05, 2003
PRIMA III TOTALSENSE TORSO COIL
K030371 · MOS
Usa Instruments, Inc.
Radiology · 90d