FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,620 results
2449–2472 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Feb 18, 2021
PhantomMSK Hip
K210136 · LLZ
OrthoGrid Systems, Inc.
Radiology · 30d
Cleared Feb 18, 2021
3D Accuitomo 150N
K201378 · OAS
J. Morita USA, Inc.
Radiology · 268d
Cleared Feb 16, 2021
Vitrea Software Package, VSTP-001A
K203312 · LLZ
Canon Medical Systems Corporation
Radiology · 98d
Cleared Feb 16, 2021
VesselIQ Xpress
K200626 · JAK
GE Medical Systems SCS
Radiology · 343d
Cleared Feb 12, 2021
4D Integrated Treatment Console
K203766 · MUJ
Varian Medical Systems, Inc.
Radiology · 51d
Cleared Feb 09, 2021
Synapse 3D, Synapse 3D Base Tools v6.1
K203103 · LLZ
Fujifilm Corporation
Radiology · 118d
Cleared Feb 09, 2021
SmartCT R1.0
K201583 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 243d
Cleared Feb 05, 2021
Cios Alpha
K210055 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 28d
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