FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,668 results
10801–10824 of 15,668
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 08, 1997
DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM
K964069 · IZH
Siemens Medical Solutions USA, Inc.
Radiology · 210d
Cleared May 08, 1997
DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111
K970813 · LLZ
Denvu, Inc.
Radiology · 64d
Cleared May 07, 1997
EUB-8000
K954220 · IYN
Hitachi Medical Corp. of America
Radiology · 604d
Cleared May 07, 1997
KODAK DIGITAL SCIENCE CARDIAC DIGITAL ACQUISITION UNIT
K970738 · IZI
Jamieson Film Co.
Radiology · 68d
Cleared May 05, 1997
SHADOWFORM
K964972 · KPQ
I.Z.I. Medical Products Corp.
Radiology · 144d
Cleared May 02, 1997
SEALED LEAD ACID BATTERY PACK
K970234 · IZL
Portable Power Systems, Inc.
Radiology · 101d
Cleared May 02, 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641 · LMD
Radiology Information Systems, Inc.
Radiology · 71d
Cleared May 02, 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652 · LMD
Mitra Imaging, Inc.
Radiology · 70d
Cleared May 01, 1997
FREEPIX/PIXPACS DICOM/HTTP GATEWAY
K970174 · LMD
Pixelinks, Inc.
Radiology · 111d
Cleared Apr 28, 1997
IMMERGE IMAGE CORRELATION
K970623 · LLZ
Surgical Navigation Technologies, Inc.
Radiology · 68d
Cleared Apr 28, 1997
CAP-35B III/CINE 275
K971128 · IXR
Jamieson Film Co.
Radiology · 32d
Cleared Apr 25, 1997
SATURNE MULTILEAF COLLIMATOR
K970303 · IXI
General Electric Co.
Radiology · 88d
Cleared Apr 24, 1997
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
K962882 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 274d
Cleared Apr 24, 1997
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
K963989 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 202d
Cleared Apr 24, 1997
CLINICAL DIAGNOSTIC SOFTWARE
K970288 · KPS
Nuccardiac Software, Inc.
Radiology · 90d
Cleared Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
K970291 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 23, 1997
CALL-RAD PC TELERADIOLOGY
K964288 · LMA
Pc Teleradiology
Radiology · 177d
Cleared Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · IYN
Hewlett-Packard Co.
Radiology · 175d
Cleared Apr 21, 1997
JANUS I
K963863 · IYO
3D Ultrasound, Inc.
Radiology · 207d
Cleared Apr 21, 1997
SOLO-SLED
K970090 · IXA
Solo-Sled, LLC
Radiology · 101d
Cleared Apr 21, 1997
EVT MARKER BOARD
K970608 · JAA
Guidant Cardiac and Vascular Surgery
Radiology · 62d
Cleared Apr 21, 1997
CT-MODELLER SYSTEM
K970617 · LLZ
Materialise NV
Radiology · 62d
Cleared Apr 21, 1997
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K970734 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Apr 16, 1997
SINUSCAN 102/SINUSPRINT
K960421 · LWI
Ferguson Medical
Radiology · 443d