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
4777–4800 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jan 28, 2015
S22 Digital Color Doppler Ultrasound System
K142815 · IYN
Sonoscape Company Limited
Radiology · 121d
Cleared Jan 26, 2015
NewTom 5G
K142222 · JAK
Qr S.R.L.
Radiology · 166d
Cleared Jan 23, 2015
omni TRAX Active Patient Tracker
K143396 · IYO
Civco Medical Instruments CO Inc Dba...
Radiology · 58d
Cleared Jan 23, 2015
RIS500
K143000 · MQB
Ray Co., Ltd.
Radiology · 98d
Cleared Jan 22, 2015
Mammography Color Display DP-M3010
K143718 · PGY
Canon, Inc.
Radiology · 24d
Cleared Jan 22, 2015
EOS System
K142773 · KPR
Eos Imaging
Radiology · 119d
Cleared Jan 22, 2015
PODIATRY X-RAY SYSTEM
K133959 · KPR
Source-Ray, Inc.
Radiology · 394d
Cleared Jan 21, 2015
ECHO TRUE 3D VIEWER
K142107 · LLZ
Echopixel, Inc.
Radiology · 173d
Cleared Jan 16, 2015
Ultrasound Scanner System bk2300
K143298 · IYN
Bk Medical Aps
Radiology · 60d
Cleared Jan 16, 2015
iMAR
K142584 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 123d
Cleared Jan 16, 2015
VM PACS WITH VM MEDICAL WORKSTATION
K141561 · LLZ
Visual Medica
Radiology · 218d
Cleared Jan 15, 2015
EVS 4343
K142475 · MQB
DRTECH Corporation
Radiology · 134d
Cleared Jan 14, 2015
SignosRT Bladder Ultrasound System
K143493 · IYO
Signostics, Ltd.
Radiology · 36d
Cleared Jan 14, 2015
NOBLUS DIAGNOSTIC ULTRASOUND SCANNER
K142368 · IYN
Hitachi Aloka Medical, Ltd.
Radiology · 142d
Cleared Jan 12, 2015
CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT
K143223 · JAK
Toshibamedical Systems Corporation
Radiology · 63d
Cleared Jan 09, 2015
INFX-8000V with Wireless Footswitch
K143225 · OWB
Toshibamedical Systems Corporation
Radiology · 60d
Cleared Jan 06, 2015
McKesson Radiology Mammography Plus
K142850 · LLZ
Mckesson Medical Imaging Company
Radiology · 98d
Cleared Jan 06, 2015
IMPAX Agility
K142316 · LLZ
Agfa Healthcare N.V.
Radiology · 140d
Cleared Jan 06, 2015
MR-CT VVA
K140587 · LLZ
Medis Medical Imaging Systems BV
Radiology · 305d
Cleared Jan 05, 2015
S9 Portable Digital Color Doppler Ultrasound System
K142710 · IYN
Sonoscape Company Limited
Radiology · 105d
Cleared Jan 02, 2015
TE7 Diagnostic Ultrasound System
K143472 · IYN
Shenzhen Mindray Bio-Medical...
Radiology · 28d
Cleared Dec 23, 2014
NExCT 7
K142697 · JAK
Neurologica Corporation
Radiology · 92d
Cleared Dec 19, 2014
TrueBeam-TrueBeam STx-Edge
K143224 · IYE
Varian Medical Systems, Inc.
Radiology · 39d
Cleared Dec 19, 2014
SMD Sr90-1 Radionuclide Brachytherapy Source
K142701 · KXK
Salutaris Medical Devices, Inc.
Radiology · 88d