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 ×
15,695 results
937–960 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 07, 2024
NeuroICH
K241719 · QAS
Neurocareai, Inc.
Radiology · 146d
Cleared Nov 07, 2024
IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector)
K241346 · MQB
Aspen Imaging Healthcare, Inc.
Radiology · 178d
Cleared Nov 07, 2024
icobrain aria
K240712 · QBS
Icometrix NV
Radiology · 237d
Cleared Nov 05, 2024
TeraRecon Cardiac.Chambers.MR (1.0.0)
K241312 · QIH
Terarecon,Inc.
Radiology · 180d
Cleared Nov 04, 2024
JLK-PWI
K242709 · LLZ
JLK, Inc.
Radiology · 56d
Cleared Nov 01, 2024
XERO-alpha
K242591 · EHD
DRTECH Corporation
Radiology · 63d
Cleared Nov 01, 2024
uDR 780i
K241068 · KPR
Shanghai United Imaging Healthcare...
Radiology · 196d
Cleared Oct 31, 2024
eRAD PACS
K241223 · LLZ
Erad, Inc.
Radiology · 183d
Cleared Oct 30, 2024
Symbia Pro.specta Q3 (11364751)
K243186 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 30, 2024
RemedyLogic AI MRI Lumbar Spine Reader
K241108 · QIH
Remedy Logic, Inc.
Radiology · 191d
Cleared Oct 29, 2024
Catheter Surface Flap Applicator Set (GM11011830)
K241965 · JAQ
Varian Medical Systems
Radiology · 118d
Cleared Oct 25, 2024
TumorSight Viz
K243189 · QIH
SimBioSys, Inc.
Radiology · 25d
Cleared Oct 25, 2024
LCD Monitors C310S, G310S, C316S, G316S, C616W
K243031 · PGY
Shenzhen Beacon Display Technology...
Radiology · 28d
Cleared Oct 25, 2024
Neurophet AQUA (V3.1)
K242215 · QIH
Neurophet., Inc.
Radiology · 88d
Cleared Oct 25, 2024
VistaPano S Ceph 2.0 (VistaPano S Ceph)
K240040 · MUH
VATECH Co., Ltd.
Radiology · 294d
Cleared Oct 24, 2024
ROCC Console
K242512 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 62d
Cleared Oct 24, 2024
Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L)
K241554 · IYN
Telefield Medical Imaging (Shenzhen)...
Radiology · 146d
Cleared Oct 23, 2024
TrueFit Bolus
K243057 · MUJ
Adaptiiv Medical Technologies, Inc.
Radiology · 26d
Cleared Oct 23, 2024
MIM – Symphony HDR Fusion
K243012 · LLZ
Mim Software, Inc.
Radiology · 26d
Cleared Oct 23, 2024
EXSYS DEXi (EXSYS DEXi-D401S-FRM)
K242847 · KPR
DRTECH Corporation
Radiology · 33d
Cleared Oct 23, 2024
Vitesse (5.0)
K241876 · MUJ
Varian Medical Systems
Radiology · 117d
Cleared Oct 22, 2024
nordicMEDiVA
K243209 · LLZ
Nordicneurolab AS
Radiology · 21d
Cleared Oct 22, 2024
ARTIS icono (VE40A) (floor)
K241572 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 144d
Cleared Oct 18, 2024
dS Wrist coil 8ch 1.5T
K243033 · MOS
Philips Medical Systems Nederland B.V.
Radiology · 21d