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
5977–6000 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 06, 2011
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K103485 · MUE
General Electric Company
Radiology · 314d
Cleared Oct 04, 2011
FLAATZ 560
K111583 · MQB
Drtech Corp.
Radiology · 119d
Cleared Oct 04, 2011
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 123d
Cleared Oct 04, 2011
APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K110870 · IYN
Toshiba America Medical Systems, In.C
Radiology · 189d
Cleared Sep 30, 2011
3DI INCLUDING CSCORE
K112530 · LLZ
Shina Systems , Ltd.
Radiology · 30d
Cleared Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293 · MOS
Time Medical Systems, Inc.
Radiology · 51d
Cleared Sep 30, 2011
IMAGELINK
K112096 · LLZ
Computer Programs and Systems, Inc.
Radiology · 70d
Cleared Sep 30, 2011
WIRED/ WIRELESS FDR D-EVO WITH X-RAY DETECTION FEATURE
K111865 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 92d
Cleared Sep 30, 2011
APEX
K111676 · IXI
Elekta Limited
Radiology · 107d
Cleared Sep 30, 2011
SURGIMAP (TM) SPINE
K111019 · LLZ
Nemaris, Inc.
Radiology · 171d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Ge Healthcare Japan Corporation
Radiology · 322d
Cleared Sep 27, 2011
SONIX ULTRASOUND SCANNER
K112726 · IYN
Ultrasonix Medical Corporation
Radiology · 7d
Cleared Sep 27, 2011
LOGIQ P3
K112371 · IYN
Ge Healthcare
Radiology · 41d
Cleared Sep 27, 2011
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 202d
Cleared Sep 26, 2011
SURGICASE ORTHOGNATHIC SOFTWARE WIZARD
K111641 · LLZ
Materialise NV
Radiology · 105d
Cleared Sep 26, 2011
21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR
K111496 · LLZ
Totoku Electric Co., Ltd.
Radiology · 118d
Cleared Sep 23, 2011
CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE
K112474 · KPS
Cedars-Sinai Medical Center
Radiology · 28d
Cleared Sep 23, 2011
VENUE 40
K112122 · IYN
Ge Healthcare
Radiology · 60d
Cleared Sep 23, 2011
LUMAGEM MOLECULAR BREAST IMAGING SYSTEM
K111791 · IYX
Gamma Medica-Ideas Incorporated
Radiology · 88d
Cleared Sep 23, 2011
CS 7600
K111649 · MUH
Carestream Health, Inc.
Radiology · 102d
Cleared Sep 23, 2011
PLANMED NUANCE EXCEL
K111361 · MUE
Planmeca USA, Inc.
Radiology · 130d
Cleared Sep 23, 2011
MAMMODIAGNOST DR
K110572 · MUE
Philips Medical Systems
Radiology · 206d
Cleared Sep 22, 2011
DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
K112022 · IYO
Advanced Instrumentations, Inc.
Radiology · 69d
Cleared Sep 22, 2011
CORONIS FUSION 4MP DL
K111989 · LLZ
Barco N.V.
Radiology · 71d