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
1921–1944 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared May 13, 2022
PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG
K221144 · MQB
Radisen Co., Ltd.
Radiology · 23d
Cleared May 13, 2022
XACT ACE Robotic System
K221116 · JAK
Xact Robotics, Ltd.
Radiology · 28d
Cleared May 13, 2022
Quantib Prostate
K221106 · LLZ
Quantib B.V.
Radiology · 28d
Cleared May 13, 2022
MAGNETOM Skyra Fit
K220589 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 73d
Cleared May 13, 2022
INTDose
K213137 · IYE
Carina Medical, LLC
Radiology · 228d
Cleared May 13, 2022
Spectral CT on Rails
K212875 · JAK
Philips Medical Systems Nederland B.V.
Radiology · 246d
Cleared May 12, 2022
Saige-Dx
K220105 · QDQ
DeepHealth, Inc.
Radiology · 120d
Cleared May 11, 2022
Versana Balance
K220446 · IYN
GE Medical Systems Ultrasound and...
Radiology · 84d
Cleared May 11, 2022
VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System),...
K212909 · IYE
Macromedics BV
Radiology · 240d
Cleared May 10, 2022
RadiForce MX243W
K221136 · PGY
Eizo Corporation
Radiology · 21d
Cleared May 10, 2022
inHEART MODELS
K220727 · LLZ
Inheart, Sas
Radiology · 57d
Cleared May 10, 2022
Overjet Caries Assist
K212519 · MYN
Overjet, Inc.
Radiology · 273d
Cleared May 06, 2022
NewTom 7G
K220664 · JAK
Cefla S.C.
Radiology · 60d
Cleared May 06, 2022
HM70 EVO Diagnostic Ultrasound System
K220269 · IYN
Samsung Medison Co., Ltd.
Radiology · 95d
Cleared May 06, 2022
KEOPS Balance Analyzer 3D
K213975 · LLZ
S.M.A.I.O
Radiology · 137d
Cleared May 06, 2022
Segment 3DPrint
K211966 · LLZ
Medviso AB
Radiology · 316d
Cleared May 05, 2022
17HQ901G-B
K220559 · MQB
Lg Electronics.Inc
Radiology · 66d
Cleared May 05, 2022
NAVIRFA Scope
K211529 · IYO
Navifus Corporation
Radiology · 353d
Cleared May 04, 2022
Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine
K220700 · IZL
Yian Medical Technology (Haining)...
Radiology · 55d
Cleared May 04, 2022
Aurora-RT
K213526 · IYE
Magnettx Oncology Solutions , Ltd.
Radiology · 181d
Cleared May 03, 2022
Cardiovascular Angiography System
K220311 · OWB
Allengers Medical Systems Limited
Radiology · 90d
Cleared May 03, 2022
exoplan
K213302 · LLZ
Exocad GmbH
Radiology · 211d
Cleared May 03, 2022
MVision AI Segmentation
K212915 · QKB
MVision AI
Radiology · 232d
Cleared May 02, 2022
Liver Suite
K211180 · JAK
GE Medical Systems SCS
Radiology · 377d