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
8377–8400 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 30, 2004
PRECISION RXI ANALOG X-RAY SYSTEM
K041605 · OWB
General Medical Merate S.P.A
Radiology · 15d
Cleared Jun 29, 2004
IMAGERAYI
K041580 · MUH
Henry Schein, Inc.
Radiology · 15d
Cleared Jun 25, 2004
ONEDOSE PATIENT DOSIMETRY SYSTEM
K040687 · IYE
Sicel Technologies, Inc.
Radiology · 101d
Cleared Jun 25, 2004
MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W
K041557 · IYE
Thomson & Nielsen Electronics, Ltd.
Radiology · 15d
Cleared Jun 25, 2004
PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
K041577 · LNH
Adac Laboratories
Radiology · 11d
Cleared Jun 24, 2004
MONOCHROME LCD MONITOR, MODEL RADIFORCE G22
K041597 · LLZ
Eizo Nanao Corporation
Radiology · 30d
Cleared Jun 23, 2004
ACCUSOFT
K040474 · MUJ
Direx Systems Corp.
Radiology · 120d