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
1345–1368 of 15,695
Search insights Median review: 81d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 17, 2023
AI Platform (AIP001)
K232501 · QIH
Exo, Inc.
Radiology · 92d
Cleared Nov 16, 2023
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
K233200 · OWB
GEMSS HEALTHCARE CO., LTD.
Radiology · 49d
Cleared Nov 16, 2023
EXPD 4343D
K232753 · MQB
DRTECH Corporation
Radiology · 69d
Cleared Nov 16, 2023
CT Lung Ventilation Analysis Software (CT:V)
K232392 · JAK
4Dmedical Limited
Radiology · 99d
Cleared Nov 15, 2023
Axial3D Insight
K232841 · QIH
Axial Medical Printing Limited
Radiology · 62d
Cleared Nov 15, 2023
BinkieRT
K231852 · IYE
Papricalab
Radiology · 145d
Cleared Nov 14, 2023
MAGNETOM Avanto fit
K232494 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 14, 2023
VitroPRO
K231783 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 151d
Cleared Nov 14, 2023
BrainSpec Core™ Software
K230856 · LLZ
Brainspec, Inc.
Radiology · 230d
Cleared Nov 13, 2023
Clarius Bladder AI
K232257 · QIH
Clarius Mobile Health Corp.
Radiology · 108d
Cleared Nov 13, 2023
BriefCase-Quantification
K232083 · QIH
Aidoc Medical , Ltd.
Radiology · 123d
Cleared Nov 09, 2023
MAGNETOM Free.Max
K231617 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 160d
Cleared Nov 09, 2023
BraveCX
K223754 · QFM
Bering, Ltd.
Radiology · 329d
Cleared Nov 08, 2023
Contour ProtégéAI
K231765 · QKB
Mim Software, Inc.
Radiology · 145d
Cleared Nov 08, 2023
BriefCase-Quantification
K230534 · QIH
Aidoc Medical , Ltd.
Radiology · 254d
Cleared Nov 07, 2023
LOGIQ E10s, LOGIQ Fortis
K231989 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 125d
Cleared Nov 07, 2023
LOGIQ E10
K231966 · IYN
GE Medical Systems Ultrasound and...
Radiology · 127d
Cleared Nov 06, 2023
Lunit INSIGHT DBT
K231470 · QDQ
Lunit, Inc.
Radiology · 168d
Cleared Nov 03, 2023
LOGIQ e
K232186 · IYN
Ge Medical Systems Ultrasound and...
Radiology · 102d
Cleared Nov 03, 2023
Halcyon, Ethos Radiotherapy System
K232113 · IYE
Varian Medical Systems, Inc.
Radiology · 112d
Cleared Nov 03, 2023
aprevo® Digital Segmentation
K231955 · QIH
Carlsmed, Inc.
Radiology · 123d
Cleared Nov 02, 2023
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F...
K230800 · KPR
GEMSS HEALTHCARE CO., LTD.
Radiology · 224d
Cleared Oct 30, 2023
BriefCase-Triage
K232751 · QAS
Aidoc Medical , Ltd.
Radiology · 52d
Cleared Oct 30, 2023
ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic...
K232145 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 103d