FDA 510(k) Regulatory Intelligence Search

Search devices, predicates, manufacturers and submission history used by regulatory affairs and medical device strategy teams.

174,883 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,433 results
5809–5832 of 15,433
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 20, 2011
VIZION DR
K112661 · MQB
Viztek, LLC
Radiology · 37d
Cleared Oct 20, 2011
PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM
K112974 · LLZ
Curve Dental, Inc.
Radiology · 15d
Cleared Oct 18, 2011
RADIOACTIVE SEED LOCALIZATION NEEDLE
K111979 · KXK
Biocompatibles, Inc.
Radiology · 98d
Cleared Oct 17, 2011
SEGMENTATION ASSISTANT FOR PROSTATE-AUTO CONTOURING
K111311 · MUJ
Omisa Inc. (Segasist Technologies)
Radiology · 160d
Cleared Oct 17, 2011
CORONIS 5MP
K111990 · LLZ
Barco N.V.
Radiology · 96d
Cleared Oct 17, 2011
SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0
K112439 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 54d
Cleared Oct 12, 2011
BEAMMED SUNLIGHT MINIOMNI BONE SONOMETER
K110646 · MUA
Beam-Med, Ltd.
Radiology · 222d
Cleared Oct 12, 2011
LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE
K112051 · LLZ
Broncus Technologies, Inc.
Radiology · 86d
Cleared Oct 12, 2011
SONOACE R7 DIAGNOSTIC ULTRASOUND SYSTEM
K112646 · IYN
Samsung Medison Co., Ltd.
Radiology · 30d
Cleared Oct 07, 2011
TOMOTHERAPY TREATMENT SYSTEM
K112446 · MUJ
Tomotherapy Incorporated
Radiology · 44d
Cleared Oct 07, 2011
MULTIPLE
K112460 · IYE
Larson Medical Products, Inc.
Radiology · 42d
Cleared Oct 06, 2011
SENOGRAPH DS, SENOGRAPH ESSENSTIAL
K103485 · MUE
General Electric Company
Radiology · 314d
Cleared Oct 06, 2011
DRYVIEW CHROMA IMAGING SYSTEM
K111566 · LMC
Carestream Health, Inc.
Radiology · 122d
Cleared Oct 04, 2011
APLIO DIAGNOSTIC ULTRASOUND SYSTEM
K110870 · IYN
Toshiba America Medical Systems, In.C
Radiology · 189d
Cleared Oct 04, 2011
OEC(R) 9800, OEC(R) 9800 PLUS
K111551 · OWB
Ge Oec Medical Systems, Inc.
Radiology · 123d
Cleared Oct 04, 2011
FLAATZ 560
K111583 · MQB
Drtech Corp.
Radiology · 119d
Cleared Sep 30, 2011
DISCOVERY MR750W 3.0T
K103327 · LNH
Ge Healthcare Japan Corporation
Radiology · 322d
Cleared Sep 30, 2011
SURGIMAP (TM) SPINE
K111019 · LLZ
Nemaris, Inc.
Radiology · 171d
Cleared Sep 30, 2011
APEX
K111676 · IXI
Elekta Limited
Radiology · 107d
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
IMAGELINK
K112096 · LLZ
Computer Programs and Systems, Inc.
Radiology · 70d
Cleared Sep 30, 2011
HTS EXTREMITY COIL, HTS SURFACE COIL
K112293 · MOS
Time Medical Systems, Inc.
Radiology · 51d
Cleared Sep 30, 2011
3DI INCLUDING CSCORE
K112530 · LLZ
Shina Systems , Ltd.
Radiology · 30d
Cleared Sep 27, 2011
HI VISION ASCENDUS DIAGNOSTIC ULTRASOUND SCANNER
K110673 · IYN
Hitachi Medical Systems America, Inc.
Radiology · 202d