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
1657–1680 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 01, 2023
Advantis Platform
K222975 · LLZ
Advantis Medical Imaging Single...
Radiology · 154d
Cleared Mar 01, 2023
Xeleris V Processing and Review System
K221680 · LLZ
Ge Healthcare
Radiology · 265d
Cleared Feb 28, 2023
AccuICAS
K221711 · QHA
ArteryFlow Technology Co., Ltd.
Radiology · 260d
Cleared Feb 24, 2023
Clarus Viewer
K222757 · LLZ
Clarus Viewer Corporation
Radiology · 165d
Cleared Feb 24, 2023
AVIEW Lung Nodule CAD
K221592 · OEB
Coreline Soft Co., Ltd.
Radiology · 267d
Cleared Feb 24, 2023
RealNow
K213891 · LLZ
Yiwei Medical Technology Co., Ltd.
Radiology · 437d
Cleared Feb 24, 2023
MAGNETOM Vida
K213805 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 445d
Cleared Feb 23, 2023
Jumong General
K230241 · KPR
Sg Healthcare Co, Ltd.
Radiology · 24d
Cleared Feb 23, 2023
Monaco RTP System
K223233 · MUJ
Elekta Solutions AB
Radiology · 127d
Cleared Feb 23, 2023
MOSAIQ® OIS (Oncology Information System)
K223229 · IYE
Elekta Solutions AB
Radiology · 128d
Cleared Feb 23, 2023
Elekta Unity
K223209 · IYE
Elekta Solutions AB
Radiology · 129d
Cleared Feb 23, 2023
Brainomix 360 e-ASPECTS
K221564 · POK
Brainomix Limited
Radiology · 268d
Cleared Feb 22, 2023
Swoop® Portable MR Imaging System™
K230208 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Feb 22, 2023
BoneMRI v1.6
K230197 · QIH
Mriguidance B.V.
Radiology · 28d
Cleared Feb 22, 2023
3D-RD-S
K212587 · IYX
Radiopharmaceutical Imaging and...
Radiology · 555d
Cleared Feb 21, 2023
NEONA 1.5T MRI System
K222259 · LNH
Time Medical Limited
Radiology · 208d
Cleared Feb 17, 2023
EzDent-i / E2 / Prora View/ Smart M Viewer
K223820 · LLZ
Ewoosoft Co., Ltd.
Radiology · 58d
Cleared Feb 17, 2023
DSPS-Prominent™ Masks
K222977 · IYE
Macromedics BV
Radiology · 142d
Cleared Feb 16, 2023
Vivid S60N, Vivid S70N
K223832 · IYN
Ge Medical System Ultrasound and...
Radiology · 56d
Cleared Feb 16, 2023
uCT ATLAS Astound with uWS-CT-Dual Energy Analysis
K223028 · JAK
Shanghai United Imaging Healthcare...
Radiology · 140d
Cleared Feb 16, 2023
uMR 680
K222755 · LNH
Shanghai United Imaging Intelligence...
Radiology · 157d
Cleared Feb 15, 2023
Digital Radiography CXDI-CS01
K230175 · MQB
Canon, Inc.
Radiology · 26d
Cleared Feb 15, 2023
Versana Essential
K223407 · IYN
GE Medical Systems Ultrasound and...
Radiology · 98d
Cleared Feb 14, 2023
8ch T/R Knee Coil
K223225 · MOS
Shenzhen RF Tech Co., Ltd.
Radiology · 119d