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
1585–1608 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 26, 2023
MR DWI/FLAIR Measurement V1.0
K230552 · LLZ
Olea Medical
Radiology · 57d
Cleared Apr 25, 2023
Konicaminolta DI-X1
K230906 · LLZ
Konica Minolta, Inc.
Radiology · 25d
Cleared Apr 25, 2023
iCAC Device
K230223 · JAK
Bunkerhill, Inc.
Radiology · 89d
Cleared Apr 25, 2023
Ceevra Reveal 3
K222676 · QIH
Ceevra, Inc.
Radiology · 231d
Cleared Apr 24, 2023
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core...
K230140 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 24, 2023
TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US)
K230136 · MWP
Compai Healthcare (Suzhou) Co.,Ltd
Radiology · 96d
Cleared Apr 21, 2023
Digital Intraoral X-Ray Sensor
K230811 · MUH
Iray Imaging Technology (Haining)...
Radiology · 28d
Cleared Apr 21, 2023
EzDent Web
K230468 · LLZ
Ewoosoft Co., Ltd.
Radiology · 59d
Cleared Apr 21, 2023
HERA W10 Diagnostic Ultrasound System
K230084 · IYN
Samsung Medison Co., Ltd.
Radiology · 100d
Cleared Apr 21, 2023
ViewFinder Software Version 1.1
K223501 · QIH
Elaitra, Ltd.
Radiology · 151d
Cleared Apr 20, 2023
Deep Learning Image Reconstruction
K230807 · JAK
Ge Healthcare Japan Corporation
Radiology · 28d
Cleared Apr 20, 2023
RadiForce RX270
K223768 · PGY
Eizo Corporation
Radiology · 126d
Cleared Apr 20, 2023
Velacur
K223287 · IYO
Sonic Incytes
Radiology · 177d
Cleared Apr 19, 2023
ART-Plan
K230023 · QKB
Therapanacea Sas
Radiology · 105d
Cleared Apr 17, 2023
Quantib Prostate
K230772 · LLZ
Quantib B.V.
Radiology · 27d
Cleared Apr 17, 2023
X-CUBE 50, X-CUBE 60
K223564 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 139d
Cleared Apr 14, 2023
AutoContour Model RADAC V3
K230685 · QKB
Radformation, Inc.
Radiology · 32d
Cleared Apr 13, 2023
UniCam Evo Software
K230393 · LLZ
Inter Medical Medizintechnik GmbH
Radiology · 58d
Cleared Apr 13, 2023
Ezra Flash
K230264 · LLZ
Ezra Ai, Inc.
Radiology · 72d
Cleared Apr 13, 2023
CerebralGo Plus
K213986 · QIH
Yukun (Beijing) Technology Co., Ltd.
Radiology · 479d
Cleared Apr 11, 2023
RCT800
K230753 · OAS
Ray Co., Ltd.
Radiology · 25d
Cleared Apr 11, 2023
Eagle S/Saevo Slim/D700 Slim
K230732 · MUH
Alliage S/A Industrias Medica...
Radiology · 26d
Cleared Apr 11, 2023
Ultrasound System 2300
K223830 · IYN
Bk Medical Aps
Radiology · 111d
Cleared Apr 11, 2023
Augmento
K222781 · LLZ
Deeptek Medical Imaging Private Limited
Radiology · 208d