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
8809–8832 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2002
CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B
K023760 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 22, 2002
KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K023772 · LLZ
Acuson Corp.
Radiology · 10d
Cleared Nov 21, 2002
ATLANTIS PV IMAGING CATHETER, MODEL 36456
K022860 · ITX
Boston Scientific, Target
Radiology · 85d
Cleared Nov 20, 2002
IMAGECHECKER-CT WORKSTATION
K023003 · LLZ
R2 Technology, Inc.
Radiology · 72d
Cleared Nov 20, 2002
SONOREAL 3D
K023473 · IYO
Bio Medi Com
Radiology · 35d
Cleared Nov 20, 2002
6 CHANNEL BODY COIL
K023571 · MOS
Siemens Medical Systems, Inc.
Radiology · 27d
Cleared Nov 20, 2002
SONOLINE ANTARES ULTRASOUND SYSTEM
K023720 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Nov 18, 2002
GORE 3.0T TORSO ARRAY
K023679 · MOS
W.L. Gore & Associates, Inc.
Radiology · 17d
Cleared Nov 14, 2002
DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM
K023434 · LHQ
Dorex, Inc.
Radiology · 30d
Cleared Nov 13, 2002
UNIVERSAL SYSTEM, MODEL QV-800
K023008 · KPR
Quantum Medical Imaging, LLC
Radiology · 65d
Cleared Nov 12, 2002
KLARITY
K022708 · IYE
Larson Products, Inc.
Radiology · 90d
Cleared Nov 08, 2002
HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY
K023398 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 08, 2002
ECAT LSO PET/CT 16
K023518 · KPS
Cti Pet Systems, Inc.
Radiology · 18d
Cleared Nov 08, 2002
MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL
K023596 · MOS
Medrad, Inc.
Radiology · 11d
Cleared Nov 07, 2002
CENTRICITY PACS PLUS
K023557 · LLZ
GE Medical Systems
Radiology · 15d
Cleared Nov 05, 2002
SIEMENS VIRTUAL SIMULATION (VSIM)
K022036 · MUJ
Siemens Medical Solutions USA, Inc.
Radiology · 134d
Cleared Nov 05, 2002
EXTRA LARGE BODY COIL
K023442 · MOS
GE Medical Systems
Radiology · 21d
Cleared Nov 05, 2002
EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2
K023511 · LNH
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Nov 05, 2002
DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS
K023586 · MQB
Canon USA, Inc.
Radiology · 11d
Cleared Nov 04, 2002
LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES
K022007 · MOS
Usa Instruments, Inc.
Radiology · 138d
Cleared Nov 01, 2002
ULTRASOUND SCANNER, TYPE 1101
K023457 · IYO
B & K Medical A/S
Radiology · 17d
Cleared Oct 30, 2002
PHILIPS DIGITAL IMAGING OPTION RELEASE 1
K023440 · LLZ
Philips Medical Systems
Radiology · 15d
Cleared Oct 30, 2002
PHILIPS MULTIDIAGNOST ELEVA
K023441 · IZI
Philips Medical Systems
Radiology · 15d
Cleared Oct 25, 2002
REAL TIME HDR (220V), MODEL 132.001
K022739 · JAQ
Nucletron Corporation
Radiology · 67d