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
1945–1968 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 17, 2022
ART-PLAN
K220813 · QKB
Therapanacea
Radiology · 88d
Cleared Jun 16, 2022
Wireless Digital Flat Panel Detector
K221345 · MQB
Iray Technology Taicang , Ltd.
Radiology · 38d
Cleared Jun 16, 2022
Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea...
K213504 · JAK
Canon Medical Systems Corporation
Radiology · 227d
Cleared Jun 15, 2022
ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System...
K221448 · IYE
Varian Medical Systems, Inc.
Radiology · 28d
Cleared Jun 15, 2022
SurgiCase Viewer
K213684 · LLZ
Materialise NV
Radiology · 205d
Cleared Jun 14, 2022
Digital Radiography CXDI-Elite, Digital Radiography E1
K221620 · MQB
Canon, Inc.
Radiology · 11d
Cleared Jun 14, 2022
ACUSON Sequoia Diagnostic Ultrasound System
K221500 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Jun 13, 2022
iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System
K221081 · IZL
First Source, Inc.
Radiology · 62d
Cleared Jun 10, 2022
Swoop Portable MR Imaging System
K221393 · LNH
Hyperfine, Inc.
Radiology · 28d
Cleared Jun 10, 2022
MediLab
K221065 · LLZ
Sigma Scientific Services, LLC
Radiology · 59d
Cleared Jun 08, 2022
HD60 Series Ultrasound Diagnostic System
K213862 · IYN
Qingdao Hisense Medical Equipment...
Radiology · 180d
Cleared Jun 08, 2022
AIR Recon DL
K213717 · LNH
Ge Medical Systems,Llc (Ge Healthcare)
Radiology · 196d
Cleared Jun 07, 2022
D²RS and D²RS 9090
K221335 · OWB
Stephanix
Radiology · 29d
Cleared Jun 07, 2022
Natural Rubber Latex Ultrasound Transducer Probe Covers
K213087 · ITX
Global Protection Corp.
Radiology · 256d
Cleared Jun 06, 2022
Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
K220358 · IYN
GE Medical Systems Ultrasound and...
Radiology · 118d
Cleared Jun 03, 2022
BriefCase
K221314 · QAS
Aidoc Medical , Ltd.
Radiology · 29d
Cleared Jun 03, 2022
21HQ613D
K221061 · PGY
Lg Electronics.Inc
Radiology · 53d
Cleared Jun 03, 2022
3D Anatomic Models
K220205 · LLZ
Ricoh USA, Inc.
Radiology · 129d
Cleared Jun 03, 2022
FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2
K214089 · ODG
Fujifilm Corporation
Radiology · 157d
Cleared Jun 03, 2022
TrueBeam, TrueBeam STx, Edge, VitalBeam
K213977 · IYE
Varian Medical Systems, Inc.
Radiology · 165d
Cleared Jun 02, 2022
Rayvolve
K220164 · QBS
Azmed Sas
Radiology · 133d
Cleared May 31, 2022
EchoNavigator R4.0
K221270 · LLZ
Philips Medical Systems Nederland B.V.
Radiology · 29d
Cleared May 31, 2022
Rapid LVO
K221248 · QAS
Ischemaview, Inc.
Radiology · 29d
Cleared May 31, 2022
EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows
K213731 · KPS
Ever Fortune.Ai, Co., Ltd.
Radiology · 186d