FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
8449–8472 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 14, 2004
NEWTOM 3G QR-DVT 9000
K041137 · OAS
Aperio Services, LLC
Radiology · 14d
Cleared May 14, 2004
MODIFICATION TO E-SCAN XQ MRI SYSTEM
K041145 · MOS
Esaote, S.P.A.
Radiology · 11d
Cleared May 14, 2004
TORSO ARRAY COIL, MODEL 558GE-64
K041185 · MOS
Igc-Medical Advances, Inc.
Radiology · 8d
Cleared May 13, 2004
COLOR LCD MONITOR, MODEL RADIFORCE R12
K040982 · LLZ
Eizo Nanao Corporation
Radiology · 28d
Cleared May 12, 2004
IMPAX OT3000 ORTHOPEDIC WORKSTATION
K040344 · LLZ
Agfa Corp.
Radiology · 90d
Cleared May 11, 2004
CRADLE PACS
K033912 · LLZ
Cradle Technology Corp.
Radiology · 146d
Cleared May 11, 2004
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D
K040585 · IYE
Brainlab AG
Radiology · 67d
Cleared May 11, 2004
STANDARD IMAGING E.IMRT CALCULATOR
K040688 · MUJ
Standard Imaging, Inc.
Radiology · 56d
Cleared May 05, 2004
DXL CALSCAN
K033550 · KGI
Demetech AB
Radiology · 175d
Cleared May 04, 2004
SECTRA IDS5 RADIOLOGY WORKSTATION
K040376 · LLZ
Sectra-Imtec AB
Radiology · 77d
Cleared May 04, 2004
ARTOSCAN C
K040877 · LNH
Esaote, S.P.A.
Radiology · 29d
Cleared Apr 29, 2004
MINRAY
K033755 · EHD
Soredex Palodex Group OY
Radiology · 150d
Cleared Apr 28, 2004
COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM
K040365 · LLZ
Barco N.V.
Radiology · 75d
Cleared Apr 28, 2004
PROTOS SOFTWARE
K040709 · IYE
Aktina Medical Physics Corp.
Radiology · 41d
Cleared Apr 28, 2004
.DECIMAL TISSUE COMPENSATOR/INTENSITY MODULATOR
K040804 · IXI
Southeastern Radiation Products, Inc.
Radiology · 30d
Cleared Apr 27, 2004
IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
K040546 · LLZ
Tomtec Imaging Systems GmbH
Radiology · 56d
Cleared Apr 23, 2004
5M MEDICAL FLAT PANEL DISPLAY, ME511L
K031661 · LLZ
Totoku Electric Co., Ltd.
Radiology · 331d
Cleared Apr 23, 2004
DICOM THEATER
K033153 · LLZ
Ferguson Medical
Radiology · 206d
Cleared Apr 23, 2004
CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO
K040468 · LLZ
Cedara Software Corp.
Radiology · 59d
Cleared Apr 23, 2004
PREVIEW TREATMENT PLANNING SOFTWARE
K040852 · LLZ
Medical Media Systems, Inc.
Radiology · 22d
Cleared Apr 23, 2004
LORAD DIGITAL SPOT MAMMOGRAPHY SYSTEM
K040884 · IZH
Hologic, Inc.
Radiology · 18d
Cleared Apr 23, 2004
TEM 3000 HEAD COIL
K040937 · MOS
Mr Instruments, Inc.
Radiology · 11d
Cleared Apr 21, 2004
HITACHI PRESTO
K040902 · JAK
Hitachi Medical Systems America, Inc.
Radiology · 14d
Cleared Apr 20, 2004
MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE
K033006 · LLZ
Barco NV Barcoview
Radiology · 270d