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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
8401–8424 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 22, 2004
OPTISOURCE, MODEL 1032P
K040766 · KXK
International Brachytherapy S.A.
Radiology · 119d
Cleared Jul 22, 2004
PATXFER RT
K040931 · LLZ
Brainlab AG
Radiology · 104d
Cleared Jul 22, 2004
3DSCOPE
K041213 · OXO
Direx Systems Corp.
Radiology · 73d
Cleared Jul 22, 2004
IMAGENMD
K041671 · KPS
Cardiovascular Imaging Technologies, LLC
Radiology · 31d
Cleared Jul 22, 2004
AFGA CR25.0 COMPUTED RADIOGRAPHY SYSTEM
K041701 · MQB
Agfa Corp.
Radiology · 30d
Cleared Jul 22, 2004
ONCENTRA-VISIR
K041719 · MUJ
Nucletron Corp.
Radiology · 28d
Cleared Jul 22, 2004
LUNG CAR 1.1
K041807 · OEB
Medicsight
Radiology · 16d
Cleared Jul 21, 2004
MAGNETOM ESPREE SYSTEM
K041112 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 84d
Cleared Jul 21, 2004
DYNACAD V1.0
K041286 · LNH
Mri Devices Corp.
Radiology · 69d
Cleared Jul 19, 2004
MODEL BBC-127 BIOPSY BREAST COIL
K041481 · MOS
Mri Devices Corp.
Radiology · 46d
Cleared Jul 16, 2004
MODIFICATION TO ENCOMPASS
K040896 · LLZ
Heartlab, Inc.
Radiology · 101d
Cleared Jul 16, 2004
MAGNETOM C! MR SYSTEM
K041111 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 79d
Cleared Jul 16, 2004
EZ-PAK (EZ-PAK IS A TRADEMARK OF IBT S.A.)
K041702 · KXK
Ibt SA
Radiology · 24d
Cleared Jul 13, 2004
CRANEX BASEX D OR CRANEX EXCEL D
K040382 · EHD
Soredex Palodex Group OY
Radiology · 147d
Cleared Jul 13, 2004
N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX
K040782 · JAK
Image Analysis, Inc.
Radiology · 109d
Cleared Jul 13, 2004
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)
K041737 · LLZ
Totoku Electric Co., Ltd.
Radiology · 15d
Cleared Jul 13, 2004
RAPIDIACOLON
K041761 · LLZ
Infinitt Co., Ltd.
Radiology · 13d
Cleared Jul 13, 2004
SHIMADZU MOBILE X-RAY SYSTEM MUX-100D SERIES
K041763 · IZL
Shimadzu Corp.
Radiology · 13d
Cleared Jul 08, 2004
LEONARDO
K040970 · LLZ
Siemens Medical Systems, Inc.
Radiology · 85d
Cleared Jul 08, 2004
KINETDX
K041029 · LLZ
Siemens Medi Cal Solutions, Inc.
Radiology · 78d
Cleared Jul 08, 2004
GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04
K041688 · IYN
General Electric Co.
Radiology · 16d
Cleared Jul 07, 2004
CADSTREAM VERSION 3.1
K041020 · LNH
Confirma, Inc.
Radiology · 78d
Cleared Jul 02, 2004
GE VIVID 7 BT04
K041552 · IYN
General Electric Co.
Radiology · 23d
Cleared Jul 02, 2004
SOURCELINK
K041576 · KXK
C.R. Bard, Inc.
Radiology · 21d