Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Radiology × Cleared only ×
15,676 results
1297–1320 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Dec 18, 2023
MAGNETOM Cima.X
K231587 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 201d
Cleared Dec 15, 2023
Sterile and Non-Sterile Ultrasound Gels
K232957 · MUI
Jianerkang Medical Co., Ltd.
Radiology · 85d
Cleared Dec 15, 2023
Videa Dental Assist
K232384 · MYN
Videahealth, Inc.
Radiology · 129d
Cleared Dec 15, 2023
Panther TPS
K231825 · MUJ
Prowess, Inc.
Radiology · 177d
Cleared Dec 15, 2023
Ziehm Vision FD
K231700 · OWB
Ziehm Imaging GmbH
Radiology · 186d
Cleared Dec 15, 2023
ARTIS pheno (VE30A)
K230949 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 255d
Cleared Dec 14, 2023
StrokeViewer Perfusion
K231570 · LLZ
Nico-Lab B.V.
Radiology · 197d
Cleared Dec 14, 2023
bright CT
K231181 · OAS
Dentium Co., Ltd (Ict Branch)
Radiology · 232d
Cleared Dec 14, 2023
ARTIS icono (VE30A)
K230950 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 254d
Cleared Dec 13, 2023
fMRI Hardware System
K232680 · LNH
Nordicneurolab AS
Radiology · 103d
Cleared Dec 13, 2023
QP-Brain®
K232231 · QIH
Quibim S.L.
Radiology · 139d
Cleared Dec 13, 2023
Endoscopic Ultrasonic Probe (P2612S-L)
K231666 · ITX
Fujifilm Healthcare Americas Corporation
Radiology · 189d
Cleared Dec 12, 2023
TeleScan
K233634 · LLZ
Bb Imaging
Radiology · 29d
Cleared Dec 12, 2023
Ziehm Solo FD
K231669 · OWB
Ziehm Imaging GmbH
Radiology · 187d
Cleared Dec 11, 2023
Nio Color 8MP (MDNC-8132)
K233693 · PGY
Barco N.V.
Radiology · 24d
Cleared Dec 11, 2023
24HR513C
K232985 · PGY
Lg Electronics.Inc
Radiology · 80d
Cleared Dec 11, 2023
Transpara Density 1.0.0
K232096 · QIH
Screenpoint Medical B.V.
Radiology · 151d
Cleared Dec 08, 2023
DVAS (DVAS-M, DVAS-W)
K232085 · EHD
Genoray Co., Ltd.
Radiology · 148d
Cleared Dec 08, 2023
DTX Studio Clinic (4.0)
K231898 · LLZ
Nobel Biocare AB
Radiology · 163d
Cleared Dec 08, 2023
Bonelogic
K223757 · QIH
Disior, Ltd.
Radiology · 358d
Cleared Dec 07, 2023
Myocardial Strain Software Application
K232661 · LLZ
Circle Cardiovascular Imaging
Radiology · 98d
Cleared Dec 07, 2023
LOGIQ Totus
K232381 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Dec 06, 2023
Sonosite LX Ultrasound System
K233597 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 28d
Cleared Dec 06, 2023
Aquilion Serve SP (TSX-307B/1) V1.3
K233334 · JAK
Canon Medical Systems Corporation
Radiology · 68d