FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
4825–4848 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 12, 2014
ANT MODEL 1
K141038 · KXK
Advanced Nuclide Technologies, LLC
Radiology · 204d
Cleared Oct 31, 2014
SoftVue
K142517 · IYO
Delphinus Medical Technologies, Inc.
Radiology · 53d
Cleared Oct 31, 2014
RAPIDRESULTS
K141881 · LLZ
Ramsoft, Inc.
Radiology · 112d
Cleared Oct 31, 2014
IQQA-BODYIMAGING SOFTWARE
K141745 · LLZ
Edda Technology
Radiology · 123d
Cleared Oct 31, 2014
PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K141700 · MUH
Genoray Co., Ltd.
Radiology · 129d
Cleared Oct 31, 2014
IMPLANT STUDIO
K141570 · LLZ
3Shape Medical A/S
Radiology · 141d
Cleared Oct 30, 2014
Site-Rite 6 Ultrasound System with Pinpoint GT Technology
K142443 · IYO
C.R. Bard, Inc.
Radiology · 58d
Cleared Oct 30, 2014
NOVAPACS
K132853 · LLZ
Novarad Corp.
Radiology · 413d
Cleared Oct 29, 2014
KUBTEC X250
K141539 · IZL
Kub Technologies, Inc.
Radiology · 141d
Cleared Oct 28, 2014
E-CUBE 12
K142884 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 26d
Cleared Oct 28, 2014
E-CUBE 5
K142733 · IYN
Alpinion Medical Systems Co., Ltd.
Radiology · 35d
Cleared Oct 28, 2014
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM, V5.0
K141459 · IYN
Toshibamedical Systems Corporation
Radiology · 148d
Cleared Oct 23, 2014
ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems
K142876 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 22d
Cleared Oct 23, 2014
Siemens 3.0 Blanket Array Coil
K142755 · MOS
Resonance Innovations, LLC
Radiology · 28d
Cleared Oct 23, 2014
PerkinElmer, XRpad 4343 F MED Flat Panel Detector
K142698 · MQB
Perkinelmer, Inc.
Radiology · 31d
Cleared Oct 23, 2014
RAYSTATION
K141860 · MUJ
Raysearch Laboratories AB
Radiology · 105d
Cleared Oct 23, 2014
SUPERNOVA C5 MRI SYSTEM
K131737 · LNH
Liaoning Kampo Medical System Co., Ltd.
Radiology · 497d
Cleared Oct 22, 2014
VERADIUS UNITY
K142708 · OWB
Philips Medical Systems Nethrlands BV
Radiology · 30d
Cleared Oct 22, 2014
UNIVERSAL DIGITAL INTERFACE 2, UDI 2
K140251 · MQB
Meridian Medical Systems, LLC
Radiology · 264d
Cleared Oct 21, 2014
FDR D-EVO II FLAT PANEL DETECTOR SYSTEM
K142003 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 90d
Cleared Oct 16, 2014
Intra-operative Ultrasound Transducer, PROSOUND ALPHA 7 Diagnostic Ultrasound...
K142618 · ITX
Hitachi Aloka Medical America, Inc.
Radiology · 30d
Cleared Oct 16, 2014
DX-D IMAGING PACKAGE
K142184 · MQB
Agfa Healthcare N.V.
Radiology · 69d
Cleared Oct 16, 2014
SYNGO CT SINGLE SOURCE DUAL ENERGY
K133677 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 321d
Cleared Oct 10, 2014
Acuson SC2000 Diagnostic Ultrasound System
K142628 · IYN
Siemens Medi Cal Solutions, Inc.
Radiology · 24d