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
1105–1128 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 10, 2024
Venue Sprint
K240206 · IYN
GE Medical Systems Ultrasound and...
Radiology · 137d
Cleared Jun 10, 2024
Venue
K240111 · IYN
GE Medical Systems Ultrasound and...
Radiology · 146d
Cleared Jun 10, 2024
Venue Go
K240053 · IYN
GE Medical Systems Ultrasound and...
Radiology · 154d
Cleared Jun 10, 2024
Venue Fit
K234106 · IYN
GE Medical Systems Ultrasound and...
Radiology · 167d
Cleared Jun 10, 2024
OmniTom Elite
K233767 · JAK
Neurologica Corporation
Radiology · 199d
Cleared Jun 07, 2024
iLoop Interventional Coil 0.55T
K241069 · MOS
Noras Mri Products GmbH
Radiology · 49d
Cleared Jun 07, 2024
Cardiac CT Function Software Application
K241038 · QIH
Circle Cardiovascular Imaging
Radiology · 52d
Cleared Jun 07, 2024
EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)
K234042 · QIH
Ever Fortune.Ai, Co., Ltd.
Radiology · 169d
Cleared May 31, 2024
CINA-VCF
K240612 · QFM
Avicenna.Ai
Radiology · 87d
Cleared May 31, 2024
Bone Suppression Software
K240281 · LLZ
Konica Minolta, Inc.
Radiology · 120d
Cleared May 31, 2024
BeamDose software (S080053)
K232738 · IYE
Ptw-Freiburg...
Radiology · 267d
Cleared May 24, 2024
SET-5002
K240827 · KPS
Shimadzu Corporation Medical Systems...
Radiology · 59d
Cleared May 24, 2024
LVivo IQS
K240769 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 64d
Cleared May 24, 2024
uPMR 790
K234154 · OUO
Shanghai United Imaging Healthcare...
Radiology · 147d
Cleared May 23, 2024
Syngo Carbon Enterprise Access (VA40A)
K240294 · LLZ
Siemens Healthcare GmbH
Radiology · 112d
Cleared May 23, 2024
VinDr-Mammo
K233108 · QFM
Vinbigdata Joint Stock Company
Radiology · 239d
Cleared May 22, 2024
Zenition 90
K240224 · OWB
Philips Medical Systems Nederlands B.V.
Radiology · 117d
Cleared May 22, 2024
IntraOp Alignment System
K240199 · OWB
Alphatec Spine, Inc.
Radiology · 118d
Cleared May 21, 2024
YSIO X.pree
K233543 · KPR
Siemens Medical Solutions
Radiology · 200d
Cleared May 21, 2024
21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01)
K233336 · PGY
Acula Technology Corp.
Radiology · 235d
Cleared May 21, 2024
Viewer (5.4)
K232759 · LLZ
Brainlab AG
Radiology · 256d
Cleared May 20, 2024
MIM - Centiloid Scaling
K233620 · LLZ
Mim Software, Inc.
Radiology · 189d
Cleared May 17, 2024
Radiance V5
K233236 · MUJ
Gmv Soluciones Globales Internet S.A.U.
Radiology · 232d
Cleared May 17, 2024
uOmnispace.CT
K233209 · QIH
Shanghai United Imaging Healthcare...
Radiology · 232d