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
961–984 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 18, 2024
Spectral CT 7500 RT
K240844 · JAK
Philips Medical Systems Technologies...
Radiology · 205d
Cleared Oct 17, 2024
SIGNA MAGNUS
K241242 · LNH
Ge Medical Systems, LLC
Radiology · 167d
Cleared Oct 16, 2024
JLK-CTP
K242556 · LLZ
JLK, Inc.
Radiology · 49d
Cleared Oct 15, 2024
cvi42 Software Application
K242781 · QIH
Circle Cardiovascular Imaging, Inc.
Radiology · 29d
Cleared Oct 15, 2024
VINT
K240385 · LLZ
Mediimg Corporation
Radiology · 250d
Cleared Oct 11, 2024
X Sensor (Model: IOS-A15IF, HDI-15DGF)
K242778 · MUH
Qpix Solutions, Inc.
Radiology · 28d
Cleared Oct 11, 2024
HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System
K241971 · IYN
Samsung Medison Co., Ltd.
Radiology · 98d
Cleared Oct 11, 2024
syngo Application Software
K241569 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Oct 10, 2024
uDR 380i Pro
K242515 · IZL
Shanghai United Imaging Healthcare...
Radiology · 48d
Cleared Oct 10, 2024
EchoMeasure
K241430 · QIH
Icardio.Ai
Radiology · 142d
Cleared Oct 10, 2024
AutoChamber
K240786 · QIH
HeartLung Corporation
Radiology · 202d
Cleared Oct 09, 2024
Limbus Contour
K241837 · QKB
Limbus Ai, Inc.
Radiology · 106d
Cleared Oct 07, 2024
SpineUs™ System
K241029 · IYO
Verdure Imaging
Radiology · 175d
Cleared Oct 07, 2024
EPIQ Series Diagnostic Ultrasound System
K240980 · IYN
Philips Ultrasound, LLC
Radiology · 180d
Cleared Oct 04, 2024
Lunit INSIGHT DBT v1.1
K242652 · QDQ
Lunit, Inc.
Radiology · 30d
Cleared Oct 04, 2024
EchoSolv AS
K241245 · POK
Echo IQ, Ltd.
Radiology · 154d
Cleared Oct 04, 2024
LVivo Software Application
K240553 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 219d
Cleared Oct 02, 2024
Versana Premier
K242005 · IYN
GE Medical Systems Ultrasound and...
Radiology · 85d
Cleared Oct 02, 2024
VitruvianScan (v1.0)
K241925 · LNH
Perspectum, Ltd.
Radiology · 93d
Cleared Oct 02, 2024
MammoScreen BD
K241561 · QIH
Therapixel
Radiology · 124d
Cleared Oct 01, 2024
Definium Pace Select ET
K242678 · KPR
Ge Hualun Medical Systems Co. , Ltd.
Radiology · 25d
Cleared Oct 01, 2024
GM85
K242651 · IZL
Samsung Electronics Co., Ltd.
Radiology · 27d
Cleared Oct 01, 2024
MuscleView
K241331 · LNH
Springbok, Inc.
Radiology · 144d
Cleared Oct 01, 2024
LungVision
K240943 · QIH
Bodyvision Medical , Ltd.
Radiology · 179d