FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
7369–7392 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 04, 2006
21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)
K063199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 45d
Cleared Nov 30, 2006
RAPID STRAND RX
K063177 · KXK
Oncura, Inc.
Radiology · 42d
Cleared Nov 30, 2006
DEL-IMS
K063188 · LLZ
Del Medical Imaging Corp.
Radiology · 41d
Cleared Nov 30, 2006
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
K063197 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
K063198 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS,...
K063312 · DQO
Boston Scientific Corp
Radiology · 28d
Cleared Nov 30, 2006
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K063342 · MOS
Medrad, Inc.
Radiology · 24d
Cleared Nov 30, 2006
SYNGO NEURO PBV CT
K063507 · JAK
Siemens AG
Radiology · 10d
Cleared Nov 28, 2006
CAAS QCA 3D
K063344 · LLZ
Pie Medical Imaging BV
Radiology · 22d
Cleared Nov 22, 2006
MODIFICATION TO EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER
K061608 · IYN
Hitachi Medical Corp.
Radiology · 166d
Cleared Nov 22, 2006
PTW DAVID IMRT QC VERIFICATION SYSTEM
K062817 · IYE
Ptw-New York Corp.
Radiology · 63d
Cleared Nov 22, 2006
IVUS ENHANCER
K062985 · LLZ
Indec Systems, Inc.
Radiology · 54d
Cleared Nov 22, 2006
PROFILER 2
K063021 · IYE
Sun Nuclear Corp.
Radiology · 51d
Cleared Nov 22, 2006
MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM
K063138 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 37d
Cleared Nov 22, 2006
XPLORER 1500 DIGITAL RADIOGRAPHIC SYSTEM WITH STAND
K063246 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 27d
Cleared Nov 22, 2006
XPLORER 1800 DIGITAL RADIOGRAPHIC SYSTEM WITH UNIVERSAL STAND
K063247 · KPR
Imaging Dynamics Company , Ltd.
Radiology · 27d
Cleared Nov 22, 2006
ORTHOVIEW
K063327 · LLZ
Merdian Technique, Ltd.
Radiology · 19d
Cleared Nov 22, 2006
DX-SI
K063421 · MQB
Agfa Corp.
Radiology · 9d
Cleared Nov 21, 2006
LONGPORT EPISCAN, MODEL-I-200
K062571 · IYO
Longport, Inc.
Radiology · 82d
Cleared Nov 21, 2006
MOD1 COMPENSATORS FOR RADIATION BEAM THERAPY
K062781 · IXI
Symtium Corporation
Radiology · 64d
Cleared Nov 21, 2006
EXCELART VANTAGE ATLAS, MODEL MRT-1503
K063361 · LNH
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 20, 2006
CADI, VERSION 4
K062237 · LLZ
Synca Marketing, Inc.
Radiology · 110d
Cleared Nov 17, 2006
NIO 5MP-M-21 (NIO 5MP MAMMO)
K062131 · LLZ
Barcoview
Radiology · 114d
Cleared Nov 17, 2006
DEFINIUM 5000 X-RAY SYSTEM
K063283 · MQB
Sedecal., Sa.
Radiology · 18d