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
10153–10176 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 05, 1999
IMFAST
K982952 · LHN
Siemens Medical Solutions USA, Inc.
Radiology · 193d
Cleared Mar 05, 1999
ACCU GUIDE
K984382 · IYO
Tayman Medical, Inc.
Radiology · 87d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990242 · KPR
I.Z.I. Medical Products Corp.
Radiology · 37d
Cleared Mar 03, 1999
TOPOGRAPHIC IMAGING MARKER
K990298 · KPR
I.Z.I. Medical Products Corp.
Radiology · 30d
Cleared Mar 02, 1999
SSA-320A JUST VISION 200/ SSA-325A JUST VISION
K990490 · IYO
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Feb 25, 1999
FLEXART,FLEXART/HYPER, VISART, VISART/HYPER
K983110 · LNH
Toshiba America Mri, Inc.
Radiology · 174d
Cleared Feb 25, 1999
HYBRISONIC SHEATH
K983985 · ITX
Sonotech, Inc.
Radiology · 108d
Cleared Feb 25, 1999
RELEASE 2 OF PHILIPS INTEGRIS SERIES (V5000, BV5000, H5000, BH5000, HM2000)...
K984545 · IZI
Philips Medical Systems North...
Radiology · 65d
Cleared Feb 24, 1999
LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM
K990400 · ITX
Hewlett-Packard Co.
Radiology · 15d
Cleared Feb 19, 1999
SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL
K983139 · MOS
GE Medical Systems
Radiology · 164d
Cleared Feb 19, 1999
TEL-ECHO SYSTEM
K990052 · LLZ
Innovative Medical Solutions, Inc.
Radiology · 43d
Cleared Feb 18, 1999
PRONOSCO X-POSURE SYSTEM
K984178 · KGI
Torsana Osteoporosis Diagnostics A/S
Radiology · 90d
Cleared Feb 18, 1999
SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O
K990339 · IYN
Hewlett-Packard Co.
Radiology · 15d
Cleared Feb 12, 1999
FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR
K984221 · LNH
Siemens Corp.
Radiology · 79d
Cleared Feb 12, 1999
ELK LASER FILM DIGITIZER
K984409 · LMA
Nishimoto Sangyo Co., Ltd.
Radiology · 65d
Cleared Feb 11, 1999
WELCH ALLYN FRONT-LINE DOC
K984215 · LLZ
Welch Allyn, Inc.
Radiology · 79d
Cleared Feb 10, 1999
VIPERSOFT
K984030 · EHD
Integra Medical
Radiology · 90d
Cleared Feb 09, 1999
GE LOGIQ700 DIAGNOSTIC ULTRASOUND SYSTEM WITH B-FLOW
K990226 · IYO
Ge Medical Systems, Inc.
Radiology · 15d
Cleared Feb 08, 1999
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
K984280 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 70d
Cleared Feb 08, 1999
ECHOLIVE FAMILY, MODELS: ZL-1010,ZL-2000,ZL-2100,ZL-3000,ZL-4000
K984405 · LMB
Intracom Corp.
Radiology · 61d
Cleared Feb 08, 1999
PHASED ARRAY FLEXIBLE CARDIAC COIL
K984588 · MOS
Philips Medical Systems (Cleveland),...
Radiology · 46d
Cleared Feb 08, 1999
IMAGEFUSION 2.0
K990071 · MUJ
Radionics, Inc.
Radiology · 28d
Cleared Feb 08, 1999
MILLENNIUM MLC -120
K990085 · IYE
Varian Assoc., Inc.
Radiology · 28d
Cleared Feb 05, 1999
CONTOUR 2000 MAMMOGRAPHY SYSTEM, MODEL CTR- 2000
K984091 · IZH
Trex Medical Corp.
Radiology · 81d