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
9985–10008 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 05, 1999
APOLLO 5, APOLLO 10
K990383 · IYE
Precitron A.B.
Radiology · 86d
Cleared Apr 30, 1999
AU6
K990360 · IYN
Biosound Esaote, Inc.
Radiology · 84d
Cleared Apr 30, 1999
ORTHOPHOS 3/3 CEPH/3 DS
K990528 · MUH
Sirona Dental Systems GmbH
Radiology · 70d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732 · MQB
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156 · JAK
Shimadzu Medical Systems
Radiology · 153d
Cleared Apr 21, 1999
SHEATHES (NON-LATEX), STERILE
K990175 · ITX
Sheathing Technologies, Inc.
Radiology · 92d
Cleared Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · JAQ
Nucletron Corp.
Radiology · 209d
Cleared Apr 16, 1999
BEACON, MODEL 211060
K983948 · KPS
Philips Medical Systems (Cleveland),...
Radiology · 162d
Cleared Apr 16, 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446 · KXK
Urocor, Inc.
Radiology · 123d
Cleared Apr 16, 1999
DICOM IMAGE MANAGER, MODEL 3-D VISUALIZATION OPTION
K990248 · IYO
Dicomit Imaging Systems Corp.
Radiology · 80d
Cleared Apr 16, 1999
SHIMADZU CEILING TUBE SUPPORT CH-30GH
K990715 · KPR
Shimadzu Corp.
Radiology · 43d
Cleared Apr 15, 1999
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR...
K983341 · JAQ
Nucletron Corp.
Radiology · 204d
Cleared Apr 15, 1999
OPART
K990260 · LNH
Toshiba America Mri, Inc.
Radiology · 78d
Cleared Apr 15, 1999
VIEW COM
K990759 · LLZ
Electromed Intl., Ltd.
Radiology · 38d
Cleared Apr 15, 1999
STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH...
K990919 · LLZ
Visualization Technology, Inc.
Radiology · 28d
Cleared Apr 07, 1999
SONOACE 6000C DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS, ALSO CALLED...
K990970 · IYN
Medison America, Inc.
Radiology · 15d
Cleared Apr 05, 1999
ANGIO-CT MIYABI
K990491 · IXI
Siemens Medical Solutions USA, Inc.
Radiology · 47d
Cleared Apr 02, 1999
FOCUS PILOT CONTOURING WORKSTATION
K981535 · IYE
Computerized Medical Systems, Inc.
Radiology · 338d
Cleared Apr 02, 1999
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
K983115 · JAQ
Nucletron Corp.
Radiology · 210d
Cleared Apr 02, 1999
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
K983337 · JAQ
Nucletron Corp.
Radiology · 191d
Cleared Apr 02, 1999
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343 · MUJ
Nucletron Corp.
Radiology · 191d
Cleared Apr 01, 1999
INTERPLANT
K982696 · MUJ
Burdette Medical Systems, Inc.
Radiology · 241d
Cleared Apr 01, 1999
QUICKRAY DSX 730
K990002 · MUH
Julie Alliance
Radiology · 87d
Cleared Apr 01, 1999
OPART, MODEL MRT-600
K990007 · MOS
Toshiba America Mri, Inc.
Radiology · 87d