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
3313–3336 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 07, 2018
uWS-CT
K173001 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 07, 2018
uWS-MR
K172999 · LLZ
Shanghai United Imaging Healthcare...
Radiology · 406d
Cleared Nov 06, 2018
icobrain
K181939 · LLZ
Icometrix NV
Radiology · 110d
Cleared Nov 06, 2018
Vivid T8, Vivid T9
K181934 · IYN
GE Medical Systems Ultrasound &...
Radiology · 110d
Cleared Nov 06, 2018
MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D
K181613 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 140d
Cleared Nov 02, 2018
Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System
K182596 · IYN
Canon Medical Systems Corporation
Radiology · 43d
Cleared Nov 02, 2018
Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System
K182427 · IYN
Canon Medical Systems Corporation
Radiology · 57d
Cleared Nov 02, 2018
Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR
K181403 · OWB
Ge Healthcare
Radiology · 157d
Cleared Nov 02, 2018
Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under...
K180601 · OAS
Villa Sistemi Medicali S.P.A.
Radiology · 240d
Cleared Oct 31, 2018
Halifax Imaging Kit
K182880 · KPR
Halifax Biomedical, Inc.
Radiology · 16d
Cleared Oct 31, 2018
Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1
K182679 · IYN
Canon Medical Systems Corporation
Radiology · 35d
Cleared Oct 31, 2018
AVIEW
K171199 · LLZ
Coreline Soft Co., Ltd.
Radiology · 555d
Cleared Oct 30, 2018
Cios Spin
K181550 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 139d
Cleared Oct 26, 2018
MAGNETOM Aera
K182299 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 63d
Cleared Oct 26, 2018
Accipiolx
K182177 · QAS
Maxq-Al , Ltd.
Radiology · 77d
Cleared Oct 26, 2018
Implant Planning Software
K173965 · LLZ
Inteware Co., Ltd.
Radiology · 301d
Cleared Oct 25, 2018
PeekMed
K182464 · LLZ
Peek Health, S.A.
Radiology · 45d
Cleared Oct 25, 2018
Vivid E80, Vivid E90, Vivid E95
K181685 · IYN
GE Medical Systems Ultrasound and...
Radiology · 121d
Cleared Oct 25, 2018
Hybrid3D
K181468 · KPS
Hermes Medical Solutions AB
Radiology · 143d
Cleared Oct 24, 2018
GC70
K182647 · KPR
Samsung Electronics Co., Ltd.
Radiology · 30d
Cleared Oct 24, 2018
Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT...
K182281 · IYO
C. R. Bard
Radiology · 62d
Cleared Oct 24, 2018
Cios Alpha
K181560 · OWB
Siemens Medical Systems USA, Inc.
Radiology · 132d
Cleared Oct 23, 2018
GU60A, GU60A-65
K182622 · KPR
Samsung Electronics Co., Ltd.
Radiology · 29d
Cleared Oct 23, 2018
Xperius Ultrasound System
K182529 · IYN
Philips Ultrasound, Inc.
Radiology · 39d