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
7033–7056 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 28, 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · LLZ
Agfa Healthcare Corporation
Radiology · 17d
Cleared Jul 25, 2008
AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX2008 WORKSTATIONS
K081963 · MQB
Agfa Healthcare Corporation
Radiology · 15d
Cleared Jul 22, 2008
SAVI APPLICATOR KIT
K081677 · JAQ
Cianna Medical, Inc.
Radiology · 35d
Cleared Jul 22, 2008
GE SIGNA MR ONCOLOGY PACKAGE
K081916 · LNH
Ge Medical Systems, LLC
Radiology · 15d
Cleared Jul 21, 2008
BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICAST
K081218 · IYE
It-V Medizintechnik, GmbH
Radiology · 82d
Cleared Jul 18, 2008
SIMPLANT ORTHO
K081402 · LLZ
Materialise Dental NV
Radiology · 60d
Cleared Jul 18, 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · LLZ
Medtronic Navigation, Inc.
Radiology · 49d
Cleared Jul 16, 2008
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
K080905 · LLZ
Quantum Medical Imaging, LLC
Radiology · 106d
Cleared Jul 16, 2008
EMP-2100 FULL DIGITAL ULTRASOUND DIAGNOSTIC DEVICE
K081873 · IYO
Shenzhen Emperor Electronic...
Radiology · 14d
Cleared Jul 15, 2008
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · LLZ
Aloka Co., Ltd.
Radiology · 15d
Cleared Jul 14, 2008
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
K081188 · IYE
Varian Medical Systems, Inc.
Radiology · 77d
Cleared Jul 11, 2008
ICI P AND S SERIES IR CAMERAS
K073581 · LHQ
Texas Infrared
Radiology · 204d
Cleared Jul 11, 2008
CX50 DIAGNOSTIC ULTRASOUND SYSTEM
K081802 · ITX
Philips Ultrasound, Inc.
Radiology · 15d
Cleared Jul 11, 2008
CAPIMAGE
K081829 · IYX
Danish Diagnostic Development A/S
Radiology · 14d
Cleared Jul 10, 2008
MODEL 7340 ULTRASOUND SYSTEM
K081794 · IYN
Esaote, S.P.A.
Radiology · 15d
Cleared Jul 09, 2008
NUWAV
K081781 · IYO
Laborie Medical Technologies, Corp.
Radiology · 15d
Cleared Jul 03, 2008
SYNGO IMAGING (VERSION V31)
K081734 · LLZ
Siemens AG Medical Solutions
Radiology · 14d
Cleared Jul 02, 2008
SONOACE X6 DIAGNOSTIC ULTRASOUND SYSTEM
K081676 · IYN
Medison Co., Ltd.
Radiology · 15d
Cleared Jul 01, 2008
LASER IMAGER DRYPRO MODEL 873
K081637 · LMC
Konica Minolta Medical & Graphic, Inc.
Radiology · 20d
Cleared Jun 24, 2008
ZURA TEE SYSTEM
K080223 · IYO
Imacor, LLC
Radiology · 147d
Cleared Jun 24, 2008
IPLAN RT IMAGE
K080886 · LHN
Brainlab AG
Radiology · 85d
Cleared Jun 24, 2008
DIGITAL RADIOGRAPHY CXDI-60G
K081648 · MQB
Canon, Inc.
Radiology · 12d
Cleared Jun 24, 2008
HD15 DIAGNOSTIC ULTRASOUND SYSTEM
K081661 · IYN
Philips Ultrasound, Inc.
Radiology · 11d
Cleared Jun 23, 2008
BIOGRAPH HD FAMILY
K081453 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 31d