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
2593–2616 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Sep 20, 2020
CORVUS
K201350 · MUJ
Best Nomos
Radiology · 122d
Cleared Sep 20, 2020
AAA Model
K200603 · LLZ
Philips Ultrasound, Inc.
Radiology · 195d
Cleared Sep 18, 2020
Caption Guidance
K201992 · QJU
Caption Health
Radiology · 63d
Cleared Sep 18, 2020
EchoPAC Software Only, EchoPAC Plug-In
K200852 · LLZ
GE Medical Systems Ultrasound and...
Radiology · 171d
Cleared Sep 16, 2020
Butterfly iQ Ultrasound System
K202406 · IYN
Butterfly Network, Inc.
Radiology · 26d
Cleared Sep 16, 2020
EOSedge
K202394 · KPR
Eos Imaging
Radiology · 26d
Cleared Sep 16, 2020
Ziehm Vision RFD 3D
K202360 · OWB
Ziehm Imaging GmbH
Radiology · 28d
Cleared Sep 16, 2020
AVA (Augmented Vascular Analysis)
K201369 · LLZ
See-Mode Technologies Pte, Ltd.
Radiology · 117d
Cleared Sep 16, 2020
PAPAYA 3D Premium & PAPAYA 3D Premium Plus
K200469 · OAS
Genoray Co., Ltd.
Radiology · 203d
Cleared Sep 15, 2020
Collaboration Live
K201665 · LLZ
Philips Ultrasound, Inc.
Radiology · 88d
Cleared Sep 11, 2020
Aline Ablation Intelligence
K202297 · LLZ
Mirada Medical, Ltd.
Radiology · 29d
Cleared Sep 10, 2020
DIAMOND-5A/6A/8A
K202156 · KPR
DRGEM Corporation
Radiology · 45d
Cleared Sep 09, 2020
3Shape Implant Studio
K202256 · LLZ
3Shape Medical A/S
Radiology · 30d
Cleared Sep 09, 2020
AcroDTI Visualizer
K201948 · LLZ
Acroviz, Inc.
Radiology · 58d
Cleared Sep 09, 2020
Vivid T8, Vivid T9
K200851 · IYN
GE Medical Systems Ultrasound and...
Radiology · 162d
Cleared Sep 09, 2020
Vivid iq
K200708 · IYN
Ge Medical Systems Ultrasound And
Radiology · 175d
Cleared Sep 08, 2020
Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit
K202014 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 49d
Cleared Sep 04, 2020
Ambra ProViewer
K202335 · LLZ
Dicom Grid Inc Dba Ambra Health
Radiology · 18d
Cleared Sep 04, 2020
SIGNA Artist
K202238 · LNH
Ge Healthcare (Tianjin) Company Limited
Radiology · 28d
Cleared Sep 03, 2020
ArtPIX DRF
K202235 · JAA
Cmt Medical Technologies, Ltd.
Radiology · 27d
Cleared Sep 03, 2020
Flat Panel Detector
K201591 · MQB
Ka Imaging, Inc.
Radiology · 83d
Cleared Sep 03, 2020
3MP Color LCD Monitors C32S+, C32SP+
K201211 · PGY
Shenzhen Beacon Display Technology...
Radiology · 121d
Cleared Sep 02, 2020
EPIQ Series Diagnostic Ultrasound Systems
K202216 · IYN
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Sep 01, 2020
Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz...
K202160 · IYN
FUJIFILM Sonosite, Inc.
Radiology · 29d