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
10705–10728 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 29, 1997
CTS-200 WITH EZU-PL21 TRANSDUCER
K963068 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990 · LNH
Philips Medical Systems, Inc.
Radiology · 237d
Cleared May 29, 1997
511 KEV COLLIMATOR
K964438 · KPS
Trionix Research Laboratory, Inc.
Radiology · 205d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · JAK
Elscint, Inc.
Radiology · 72d
Cleared May 28, 1997
NOTEBOOK IMAGER
K961104 · IYX
Digirad Corp.
Radiology · 434d
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