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
9313–9336 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 03, 2001
3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL
K003613 · MOS
GE Medical Systems
Radiology · 132d
Cleared Apr 03, 2001
ULTRASOUND SCANNER TYPE 2102
K003986 · IYN
B & K Medical A/S
Radiology · 98d
Cleared Apr 03, 2001
MODEL 455GE PHASED ARRAY WRIST COIL
K010074 · MOS
Medical Advances, Inc.
Radiology · 84d
Cleared Apr 03, 2001
THINKINGNET
K010271 · LLZ
Thinking Systems Corp.
Radiology · 64d
Cleared Apr 03, 2001
MAMMOGRAPH
K010792 · IZH
Digitec Medical Service Corp.
Radiology · 18d
Cleared Apr 02, 2001
AT3C70 TRANSDUCER
K002856 · ITX
Sonora Medical Systems
Radiology · 201d
Cleared Apr 02, 2001
COUCH FOR TOTAL BODY RADIATION
K010063 · IYE
Arplay Medical S.A.
Radiology · 84d
Cleared Apr 02, 2001
PHILIPS BV LIBRA
K010762 · OXO
Philips Medical Systems, Inc.
Radiology · 19d
Cleared Mar 30, 2001
GE CT-PET SYSTEM
K010641 · JAK
Ge Medical Systems, Inc.
Radiology · 25d
Cleared Mar 30, 2001
AXIOM ARTIS MODULAR ANGIOGRAPHY SYSTEM
K010721 · IZI
Siemens Medical Corp.
Radiology · 18d
Cleared Mar 29, 2001
ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975
K010707 · DQO
Boston Scientific, Target
Radiology · 20d
Cleared Mar 28, 2001
ADC QS/IPD WORKSTATION
K010571 · LLZ
Agfa Corp.
Radiology · 30d
Cleared Mar 21, 2001
MEDEVIEW SYSTEM
K002789 · LLZ
Medeview.Com
Radiology · 195d
Cleared Mar 21, 2001
IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK
K010058 · LLZ
Witt Biomedical Corporation
Radiology · 72d
Cleared Mar 20, 2001
EXHALE DOPPLER SYSTEM
K010649 · IYN
Broncus Technologies, Inc.
Radiology · 15d
Cleared Mar 15, 2001
IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM
K003899 · LNH
Mri Devices Corp.
Radiology · 87d
Cleared Mar 15, 2001
PLANMED SOPHIE, PLANMED SOPHIE CLASSIC
K010116 · IZH
Planmed OY
Radiology · 58d
Cleared Mar 15, 2001
OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTER
K010591 · ODG
Olympus Optical Co., Ltd.
Radiology · 15d
Cleared Mar 15, 2001
NEMIO
K010631 · IYN
Toshiba America Medical Systems, In.C
Radiology · 13d
Cleared Mar 13, 2001
3D-DOCTOR
K003746 · LLZ
Able Software Corp.
Radiology · 99d
Cleared Mar 13, 2001
FUNCTIONAL BRAIN MAPPING OPTION FOR MRI
K003947 · LNH
GE Medical Systems
Radiology · 82d
Cleared Mar 13, 2001
BEAM BLOCK TRAYS
K004015 · IYE
Arplay Medical S.A.
Radiology · 76d
Cleared Mar 13, 2001
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM
K010062 · IYE
Arplay Medical S.A.
Radiology · 64d
Cleared Mar 13, 2001
7230 ULTRASOUND IMAGING SYSTEM WITH TEI
K010405 · IYN
Biosound Esaote, Inc.
Radiology · 29d