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
2521–2544 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 05, 2021
Cios Spin
K210054 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 28d
Cleared Feb 05, 2021
LVivo Software Application
K210053 · QIH
Dia Imaging Analysis, Ltd.
Radiology · 28d
Cleared Feb 05, 2021
X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy...
K203374 · MUH
De G?tzen S.R.L.
Radiology · 81d
Cleared Feb 05, 2021
Bonelogic
K203290 · LLZ
Disior, Ltd.
Radiology · 88d
Cleared Feb 04, 2021
QUIBIM Precision Prostate (qp-Prostate)
K203582 · LLZ
Quibim S.L.
Radiology · 59d
Cleared Feb 02, 2021
EzRay M (Model: VMX-P300)
K203667 · IZL
VATECH Co., Ltd.
Radiology · 48d
Cleared Feb 02, 2021
Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR
K203553 · LNH
Canon Medical Systems Corporation
Radiology · 60d
Cleared Feb 02, 2021
CTxx85 CT Scanner
K201231 · JAK
Analogic Corporation
Radiology · 271d
Cleared Feb 01, 2021
Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems
K203537 · KPR
Sedecal., Sa.
Radiology · 60d
Cleared Jan 29, 2021
Visage Breast Density
K201411 · QIH
Visage Imaging GmbH
Radiology · 246d
Cleared Jan 29, 2021
i_Space 1.5T Superconducting Magnetic Resonance Imaging System
K192650 · LNH
Mri Division,Beijing Wandong Medical...
Radiology · 493d
Cleared Jan 26, 2021
General Radiography CXDI-CS01
K203849 · MQB
Canon, Inc.
Radiology · 26d
Cleared Jan 26, 2021
IBM iConnect Access
K203104 · LLZ
Merge Healthcare Incorporated
Radiology · 104d
Cleared Jan 25, 2021
vatech A9 (Model : PHT-30CSS)
K203797 · OAS
VATECH Co., Ltd.
Radiology · 28d
Cleared Jan 25, 2021
Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp,...
K202856 · IYN
Edan Instruments, Inc.
Radiology · 119d
Cleared Jan 25, 2021
Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory
K202742 · IYN
Viasonix , Ltd.
Radiology · 129d
Cleared Jan 22, 2021
Platinum dRF Imaging System
K203010 · JAA
Apelem-Dms Group
Radiology · 113d
Cleared Jan 15, 2021
ViewPoint 6
K203677 · LLZ
GE Medical Systems Ultrasound &...
Radiology · 29d
Cleared Jan 15, 2021
Veuron-Brain-pAb
K203142 · LLZ
Heuron Co., Ltd.
Radiology · 87d
Cleared Jan 15, 2021
AccuBrain
K202847 · LLZ
Brainnow Medical Technology Limited
Radiology · 112d
Cleared Jan 15, 2021
Vantage Orian 1.5T, MRT-1550, V6.0
K202767 · LNH
Canon Medical Systems Corporation
Radiology · 116d
Cleared Jan 15, 2021
uAI EasyTriage-Rib
K193271 · QFM
Shanghai United Imaging Intelligence...
Radiology · 416d
Cleared Jan 14, 2021
Mobius3D
K203669 · IYE
Varian Medical Systems, Inc.
Radiology · 29d
Cleared Jan 14, 2021
ART-Plan
K202700 · QKB
Therapanacea
Radiology · 120d