FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
73–96 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Jun 04, 2026
Respiratory Gating for Scanners (2.1)
K253026 · JAK
Varian Medical Systems, Inc.
Radiology · 258d
Cleared Jun 04, 2026
LUNA 3D
K253004 · IYE
Lap GmbH Laser Applikationen
Radiology · 258d
Cleared Jun 03, 2026
HeartFocus
K260780 · QJU
Deski
Radiology · 85d
Cleared Jun 03, 2026
CustoMED Viewer
K260116 · LLZ
CustoMED , Ltd.
Radiology · 140d
Cleared May 29, 2026
OrthoGrid Hip AI® 4.0
K260077 · QIH
OrthoGrid Systems, Inc.
Radiology · 137d
Cleared May 29, 2026
Nexus DRF Digital X-ray Imaging System
K253103 · JAA
Varex Imaging Corporation
Radiology · 247d
Cleared May 29, 2026
HistoSonics® Planning Tool
K252947 · QTZ
HistoSonics, Inc.
Radiology · 256d
Cleared May 28, 2026
ANDI 2.2
K261405 · QIH
Imeka Solutions, Inc.
Radiology · 29d
Cleared May 28, 2026
Bellalun 2D (VDMS-1000S)
K254092 · MUE
Vieworks Co., Ltd.
Radiology · 160d
Cleared May 27, 2026
EPIQ Series Diagnostic Ultrasound Systems
K260680 · IYN
Philips Ultrasound, LLC
Radiology · 86d