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
4873–4896 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Oct 10, 2014
Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System
K142323 · IYN
Ge Medical Systems Israel , Ltd.
Radiology · 51d
Cleared Oct 10, 2014
LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
K142160 · IYN
Ge Healthcare
Radiology · 65d
Cleared Oct 10, 2014
QUANTRA
K142037 · LLZ
Hologic, Inc.
Radiology · 74d
Cleared Oct 08, 2014
MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi...
K142515 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 30d
Cleared Oct 08, 2014
CLARITY
K141855 · IYE
Elekta , Ltd.
Radiology · 91d
Cleared Oct 03, 2014
24.1 inch (61.1 cm) Color LCD Monitor CCL244 (CL24244)
K142540 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 03, 2014
21.5 inch (54.5 cm) Color LCD Monitor CCL220 (CL22220)
K142536 · PGY
Jvckenwood Corporation
Radiology · 24d
Cleared Oct 03, 2014
UGEO PT60A Diagnostic Ultrasound System
K142466 · IYN
Samsung Medison Co., Ltd.
Radiology · 31d
Cleared Oct 03, 2014
FDR D-EVO FLAT PANEL DETECTOR SYSTEM
K141765 · MQB
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 94d
Cleared Oct 03, 2014
FUSION DIGITAL DIAGNOSTIC X-RAY UPGRADE KIT
K141743 · MQB
Radiology Solutions, LLC
Radiology · 95d
Cleared Oct 02, 2014
Varian Verification System (VVS)
K142268 · IYE
Varian Medical Systems, Inc.
Radiology · 48d
Cleared Sep 29, 2014
IMACOR ZURA EVO IMAGING SYSTEM
K142054 · IYO
Imacor, Inc.
Radiology · 62d
Cleared Sep 26, 2014
DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA...
K142085 · LNH
Ge Medical Systems, LLC
Radiology · 57d
Cleared Sep 26, 2014
PERFRACTION
K141800 · IYE
Sun Nuclear Corporation
Radiology · 85d
Cleared Sep 26, 2014
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
K141490 · JAQ
Varian Medical Systems, Inc.
Radiology · 113d
Cleared Sep 26, 2014
AERODR SYSTEM 2
K141271 · MQB
Konica Minolta, Inc.
Radiology · 134d
Cleared Sep 26, 2014
OPERA SWING
K140380 · JAA
General Medical Merate S.P.A
Radiology · 224d