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
169–192 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jun 18, 2026
Portable DR Imaging System
K253058 · IZL
Shantou Institute of Ultrasonic...
Radiology · 269d
Cleared Jun 18, 2026
RadOncAI
K253050 · MUJ
Informai
Radiology · 269d
Cleared Jun 17, 2026
Non-Sterile Ultrasound Gel Sterile Ultrasound Gel
K253255 · MUI
Foshan Pingchuang Medical Technology...
Radiology · 261d
Cleared Jun 16, 2026
ACUSON Sequoia Diagnostic Ultrasound System
K260844 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Jun 16, 2026
myAblation Guide (VC10A)
K253264 · QTZ
Siemens Healthcare GmbH
Radiology · 260d
Cleared Jun 15, 2026
DRE Duo
K260482 · KPR
Jpi Healthcare Co, Ltd.
Radiology · 122d
Cleared CT Jun 15, 2026
WatchMate Software
K260300 · QIH
Anumana, Inc.
Radiology · 136d
Cleared Jun 15, 2026
Saige-Dx
K253825 · QDQ
DeepHealth, Inc.
Radiology · 196d
Cleared Jun 15, 2026
LungMaps
K253690 · QIH
Siemens Healthineers AG
Radiology · 206d
Cleared Jun 15, 2026
MediAI-OA
K253172 · QIH
Crescom Co., Ltd.
Radiology · 262d
Cleared Jun 12, 2026
Medical Monitor (40HT513D)
K261213 · PGY
Lg Electronics.Inc
Radiology · 59d
Cleared Jun 12, 2026
Brainomix 360 Hyperdensity
K260406 · QIH
Brainomix Limited
Radiology · 123d
Cleared Jun 12, 2026
Universal 1417PI
K252996 · MQB
Konica Minolta Healthcare Americas, Inc.
Radiology · 267d
Cleared Jun 12, 2026
ThinkQA 3
K252937 · IYE
Dosisoft SA
Radiology · 270d
Cleared Jun 11, 2026
Acorn 3D Software (AC-SEG-4009)
K260322 · QIH
Mighty Oak Medical
Radiology · 132d
Cleared Jun 11, 2026
PROBEAT-CR
K260174 · LHN
Hitachi High-Tech Corp.
Radiology · 141d
Cleared Jun 11, 2026
Dental X-ray System
K250839 · OAS
Changzhou Boen Zhongding Medical...
Radiology · 448d
Cleared Jun 10, 2026
DeepXray Spina
K253192 · SAO
Alpha Intelligence Manifolds, Inc.
Radiology · 257d
Cleared Jun 09, 2026
ES-Series
K260748 · IYN
E-Scopics
Radiology · 95d
Cleared Jun 08, 2026
2D Hip Planning Software
K261352 · LLZ
One Ortho
Radiology · 45d
Cleared Jun 05, 2026
Digital C-ARM with 3D
K253296 · OXO
Allengers Medical Systems Limited
Radiology · 249d
Cleared Jun 04, 2026
Sonio Suspect
K261519 · POK
Sonio
Radiology · 28d
Cleared Jun 04, 2026
Dental Cone Beam Computed Tomography System
K260662 · OAS
Yofo Medical Technology Co., Ltd.
Radiology · 94d
Cleared Jun 04, 2026
DEEPVESSEL Plaque
K260497 · QIH
Keya Medical Technology Co., Ltd.
Radiology · 111d