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
2401–2424 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 21, 2021
Universal Viewer
K211312 · LLZ
Ge Healthcare
Radiology · 21d
Cleared May 20, 2021
C-Qual M™ Breastboard
K211001 · IYE
Medtec, Inc. Dba Civco Medical...
Radiology · 48d
Cleared May 20, 2021
Xoran Workstation, Model 10050
K210257 · LLZ
Xoran Technologies, LLC
Radiology · 108d
Cleared May 19, 2021
Vereos PET/CT
K210880 · KPS
Philips Medical Systems Nederland B.V.
Radiology · 56d
Cleared May 19, 2021
CINA CHEST
K210237 · QAS
Avicenna.Ai
Radiology · 111d
Cleared May 19, 2021
Overjet Dental Assist
K210187 · LLZ
Overjet, Inc.
Radiology · 114d
Cleared May 17, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K211037 · LNH
Canon Medical Systems Corporation
Radiology · 40d
Cleared May 17, 2021
Cercare Medical Neurosuite
K202793 · LLZ
Cercare Medical Aps
Radiology · 237d
Cleared May 14, 2021
HOLOSCOPE-i
K210072 · LLZ
Real View Imaging , Ltd.
Radiology · 123d
Cleared May 14, 2021
Klarity Bolus
K202747 · IYE
Klarity Medical & Equipment (GZ) Co.,...
Radiology · 235d
Cleared May 13, 2021
SIGNA 7.0T
K211118 · LNH
Ge Medical Systems, LLC
Radiology · 28d
Cleared May 13, 2021
HS40 Diagnostic Ultrasound System
K210426 · IYN
Samsung Medison Co., Ltd.
Radiology · 91d
Cleared May 12, 2021
Symbia VA10A Family
K210557 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared May 06, 2021
Corvus Radiation Therapy Planning System
K211034 · MUJ
Best Nomos
Radiology · 29d
Cleared May 06, 2021
ImagePilot
K210066 · LLZ
Konica Minolta, Inc.
Radiology · 115d
Cleared May 04, 2021
SOTA Cloud Imaging
K210682 · LLZ
Sota Precision Optics, Inc. Dba Sota...
Radiology · 57d
Cleared May 04, 2021
PtoleMedic System
K202521 · LLZ
Lento Medical Innovation, Inc.
Radiology · 245d
Cleared Apr 30, 2021
AcuityDRe
K210919 · MQB
Radmedix, LLC
Radiology · 32d
Cleared Apr 30, 2021
HYPER AiR
K210001 · KPS
Shanghai United Imaging Healthcare...
Radiology · 116d
Cleared Apr 30, 2021
syngo. CT Extended Functionalities
K203699 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 133d
Cleared Apr 28, 2021
1717FCC
K210985 · MQB
Rayence Co., Ltd.
Radiology · 27d
Cleared Apr 28, 2021
AMX Navigate
K210982 · IZL
Ge Medical Systems, LLC
Radiology · 27d
Cleared Apr 28, 2021
Trinias
K203535 · OWB
Shimadzu Corporation Medical Systems
Radiology · 146d
Cleared Apr 28, 2021
TCL3 Motion Tracking System
K203451 · LNH
Tracinnovations Aps
Radiology · 156d