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
2473–2496 of 15,676
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 12, 2021
ADD
K203188 · MQB
H&abyz Co., Ltd.
Radiology · 136d
Cleared Mar 12, 2021
Oncospace
K202284 · MUJ
Oncospace, Inc.
Radiology · 212d
Cleared Mar 10, 2021
Vantage Elan 1.5T, MRT-2020, V6.0
K210164 · LNH
Canon Medical Systems Corporation
Radiology · 48d
Cleared Mar 09, 2021
Quicktome
K203518 · LLZ
Omniscient Neurotechnology Pty Ltd (O8t)
Radiology · 98d
Cleared Mar 09, 2021
Imbio RV/LV Software
K203256 · QIH
Imbio, LLC
Radiology · 125d
Cleared Mar 05, 2021
Cios Select (VA21) Flat Panel
K210309 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 05, 2021
OEC 3D
K203346 · OXO
Ge Oec Medical Systems, Inc.
Radiology · 112d
Cleared Mar 05, 2021
Akesis Galaxy RTi
K203146 · IWB
Akesis, Inc.
Radiology · 135d
Cleared Mar 05, 2021
Vivid E80/ Vivid E90/ Vivid E95
K202658 · IYN
GE Medical Systems Ultrasound and...
Radiology · 172d
Cleared Mar 05, 2021
Optellum Virtual Nodule Clinic, Optellum software, Optellum platform
K202300 · POK
Optellum, Ltd.
Radiology · 204d
Cleared Mar 04, 2021
Cios Select (VA21) Image Intensifier
K210307 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 29d
Cleared Mar 04, 2021
AlignRT Plus
K203387 · IYE
Vision Rt, Ltd.
Radiology · 106d
Cleared Mar 04, 2021
Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR
K203323 · LNH
Canon Medical Systems Corporation
Radiology · 112d
Cleared Mar 03, 2021
Mars 1417X Wireless Digital Flat Panel Detector
K210316 · MQB
Iray Technology Taicang , Ltd.
Radiology · 28d
Cleared Mar 03, 2021
Biograph Vision Quadra PET/CT System
K210262 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Mar 03, 2021
Promaxo MRI System
K202518 · LNH
Promaxo, Inc.
Radiology · 183d
Cleared Mar 02, 2021
Mars1717X Wireless Digital Flat Panel Detector
K210314 · MQB
Iray Technology Taicang , Ltd.
Radiology · 27d
Cleared Mar 02, 2021
MRI PPG Patient Cable
K203653 · LNH
Ivy Biomedical Systems, Inc.
Radiology · 77d
Cleared Mar 02, 2021
MaxFOV 2
K203617 · JAK
Ge Medical Systems, LLC
Radiology · 81d
Cleared Mar 02, 2021
SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G...
K201965 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 230d
Cleared Feb 26, 2021
Cuptimize
K203651 · LLZ
Cuptimize, Inc.
Radiology · 74d
Cleared Feb 26, 2021
SubtleMR
K203182 · LLZ
Subtle Medical, Inc.
Radiology · 122d
Cleared Feb 26, 2021
Spectral CT
K203020 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 147d
Cleared Feb 26, 2021
SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System
K201968 · IYN
CHISON Medical Technologies Co., Ltd.
Radiology · 226d