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
9073–9096 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 22, 2002
MEDSTONE, UROPRO 2000, TOMOGRAPHIC OPTION
K013620 · IZF
Medstone Intl., Inc.
Radiology · 78d
Cleared Jan 22, 2002
INFINION 0.6T MR IMAGING SYSTEM
K013858 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 62d
Cleared Jan 18, 2002
EVTOOL MODEL # V. 1.0
K013535 · MUJ
3D Line USA, Inc.
Radiology · 87d
Cleared Jan 18, 2002
TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T
K013894 · MOS
Philips Medical Systems North...
Radiology · 56d
Cleared Jan 17, 2002
3DFIS, MODEL IES-FL-101
K013841 · LLZ
3Dsharp, Inc.
Radiology · 58d
Cleared Jan 16, 2002
KONICA LASER IMAGER, DRYPRO MODEL 751/752
K013052 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 127d
Cleared Jan 16, 2002
PLANMED SOPHIE & PLANMED SOPHIE CLASSIC
K013656 · IZH
Planmed OY
Radiology · 71d
Cleared Jan 16, 2002
LOGIQBOOK
K014206 · IYO
General Electric Co.
Radiology · 26d
Cleared Jan 15, 2002
ACCENT
K013574 · LLZ
Confirma, Inc.
Radiology · 78d
Cleared Jan 11, 2002
BODYFIX
K013391 · IYE
Medical Intelligence Medizintechnik GmbH
Radiology · 88d
Cleared Jan 10, 2002
GE LOGIQ 5
K014097 · IYN
GE Medical Systems
Radiology · 29d
Cleared Jan 08, 2002
EXTREMITY COIL
K013592 · MOS
Usa Instruments, Inc.
Radiology · 70d
Cleared Jan 07, 2002
M2540 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL M2540
K014191 · IYN
Philips Medical Systems
Radiology · 17d
Cleared Jan 03, 2002
TETRAD MODEL TC-C52-, -C84V-, -C95-, -CLA76-, -L74-ATP TRANSDUCERS
K014182 · ITX
Tetrad Corp.
Radiology · 14d
Cleared Jan 02, 2002
CANON X-RAY DIGITAL CAMERA, MODEL CXDI-31
K003689 · IXK
Canon USA, Inc.
Radiology · 398d
Cleared Jan 02, 2002
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
K013514 · MOS
Mri Devices Corp.
Radiology · 72d
Cleared Dec 28, 2001
MAGNETOM TRIO SYSTEM
K013586 · LNH
Siemens Medical Systems, Inc.
Radiology · 59d
Cleared Dec 28, 2001
SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER
K013721 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 49d
Cleared Dec 21, 2001
DIGIPAN / DPI
K012514 · MUH
Trophy Radiologie
Radiology · 137d
Cleared Dec 21, 2001
ENTEGRA PE PERSONAL DIGITAL ASSISTANT
K014058 · LLZ
General Electric Medical Systems
Radiology · 11d
Cleared Dec 20, 2001
CSIST DICOM GATEWAY/IMAGE MANAGER
K012327 · LLZ
Csist
Radiology · 150d
Cleared Dec 20, 2001
FUJI SPEED SUITE, FUJI SPEED SUTE PHASE II
K013218 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 85d
Cleared Dec 20, 2001
NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM
K013419 · LLZ
Nicolet Biomedical
Radiology · 66d
Cleared Dec 20, 2001
HAND-CARRIED ULTRASOUND SYSTEM
K014116 · IYN
Sonosite,Inc.
Radiology · 6d