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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10609–10632 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 28, 1997
THERATON 1000E
K964607 · IWD
Theratronics, Inc.
Radiology · 191d
Cleared May 20, 1997
OUR ROTATING GAMMA SYSTEM
K970647 · IWB
Our Scientific Intl., Inc.
Radiology · 89d
Cleared May 20, 1997
HOWTEK 960
K970908 · LMA
Howtek, Inc.
Radiology · 70d
Cleared May 20, 1997
SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR
K970999 · JAK
Sony Medical Systems
Radiology · 62d
Cleared May 20, 1997
UMI X-RAY FILM CASSETTE
K971431 · IXA
Umi Intl.
Radiology · 33d
Cleared May 14, 1997
SCANRITE DFS
K970850 · EHD
Scanrite Systems
Radiology · 68d
Cleared May 14, 1997
B-350 CEILING MOUNTED C-POSITIONER
K970947 · JAA
Omega Medical Imaging, Inc.
Radiology · 61d
Cleared May 14, 1997
PHILIPS INTEGRIS H5000
K971365 · IZI
Philips Medical Systems North...
Radiology · 30d
Cleared May 14, 1997
MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE
K971452 · IZZ
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared May 12, 1997
DYNAMIC WEDGE
K970564 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 88d
Cleared May 12, 1997
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
K970586 · IYE
Brainlab Med. Computersysteme GmbH
Radiology · 87d
Cleared May 12, 1997
GE ADVANTAGE DIGITIZER WORKSTATION
K970628 · LMD
Ge Medical Systems, Inc.
Radiology · 82d
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