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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology × Cleared only ×
15,488 results
10033–10056 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Feb 05, 1999
PROFILE 2000 MAMMOGRAPHY SYSTEM, PRO-2000
K984092 · IZH
Trex Medical Corp.
Radiology · 81d
Cleared Feb 02, 1999
PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS
K984224 · LNH
Siemens Corp.
Radiology · 69d
Cleared Feb 02, 1999
XISCAN OFFICE EXPERT IMAGING SYSTEM, XISCAN SURGICAL EXPERT IMAGING SYSTEM
K984406 · OXO
Xitec, Inc.
Radiology · 55d
Cleared Feb 02, 1999
B-400 CEILING MOUNTED POSSITIONER, MODEL B-400
K990055 · JAA
Omega Medical Imaging, Inc.
Radiology · 26d
Cleared Jan 25, 1999
BLADDERMANAGER PCI 5000 MODEL 1002
K982568 · ITX
Diagnostic Ultrasound Corp.
Radiology · 186d
Cleared Jan 25, 1999
KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE...
K983905 · LMC
Eastman Kodak Company
Radiology · 83d
Cleared Jan 25, 1999
IMATION TRIMATIC DIGITAL SYSTEM
K984252 · LMA
Imation Corp.
Radiology · 59d
Cleared Jan 25, 1999
MEDRAD PHASED ARRAY NEUROVASCULAR COIL
K984257 · MOS
Medrad, Inc.
Radiology · 56d
Cleared Jan 25, 1999
MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE
K984274 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 56d
Cleared Jan 15, 1999
ELEKTA ONCOLOGY SYSTEMS PRECISE TREATMENT TABLE
K983678 · JAI
Elekta Instruments, Inc.
Radiology · 87d
Cleared Jan 14, 1999
VISIONS 8.2F PV ULTRASONIC IMAGING CATHETER (MODEL 88900)
K982329 · ITX
Endosonics Corp.
Radiology · 196d
Cleared Jan 14, 1999
PACSCACHE
K983815 · LLZ
Dome Imaging Systems, Inc.
Radiology · 78d