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
10633–10656 of 15,488
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Apr 24, 1997
SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM
K962882 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 274d
Cleared Apr 24, 1997
P.D. ACCESS (PERCUTANEOUS DOPPLER) VASCULAR ACCESS DEVICE
K963989 · ITX
Cardiovascular Dynamics, Inc.
Radiology · 202d
Cleared Apr 24, 1997
CLINICAL DIAGNOSTIC SOFTWARE
K970288 · KPS
Nuccardiac Software, Inc.
Radiology · 90d
Cleared Apr 24, 1997
ACCESSORIES TO THE STEREOTACTIC BODY FRAM
K970291 · IYE
Elekta Instrument AB
Radiology · 90d
Cleared Apr 23, 1997
CALL-RAD PC TELERADIOLOGY
K964288 · LMA
Pc Teleradiology
Radiology · 177d
Cleared Apr 22, 1997
SONOS 2000, SONOS 2500 (M2406 A)
K964309 · IYN
Hewlett-Packard Co.
Radiology · 175d
Cleared Apr 21, 1997
JANUS I
K963863 · IYO
3D Ultrasound, Inc.
Radiology · 207d
Cleared Apr 21, 1997
SOLO-SLED
K970090 · IXA
Solo-Sled, LLC
Radiology · 101d
Cleared Apr 21, 1997
EVT MARKER BOARD
K970608 · JAA
Guidant Cardiac and Vascular Surgery
Radiology · 62d
Cleared Apr 21, 1997
CT-MODELLER SYSTEM
K970617 · LLZ
Materialise NV
Radiology · 62d
Cleared Apr 21, 1997
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K970734 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Apr 16, 1997
SINUSCAN 102/SINUSPRINT
K960421 · LWI
Ferguson Medical
Radiology · 443d
Cleared Apr 16, 1997
EXPANDED REFERENCE VALUES FOR DPX BON DENSITOMETERS
K964307 · KGI
Lunar Corp.
Radiology · 169d
Cleared Apr 16, 1997
PIXI BONE DENSITOMETER
K970224 · KGI
Lunar Corp.
Radiology · 85d
Cleared Apr 16, 1997
STATNET
K970525 · IZI
Gorca Systems, Inc.
Radiology · 64d
Cleared Apr 15, 1997
EXL-12SP,12DP,15DP,20DP LINAC
K970137 · IYE
Mitsubishi Electronics America, Inc.
Radiology · 90d
Cleared Apr 11, 1997
ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)
K970128 · KPS
Park Medical Systems, Inc.
Radiology · 87d
Cleared Apr 07, 1997
DOWNSCAN 120
K970451 · LLZ
Merlin Engineering Works, Inc.
Radiology · 60d
Cleared Apr 04, 1997
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · IWZ
Eastman Kodak Company
Radiology · 78d
Cleared Apr 04, 1997
IMEX FUTURALDOP PRO
K970156 · IYO
Imex Medical Systems, Inc.
Radiology · 78d
Cleared Apr 04, 1997
PICTURE ARCHIVING & COMMUNICATIONS DEVICE
K970534 · LLZ
Multimedia Solutions
Radiology · 51d
Cleared Apr 04, 1997
COMPUTED TOMOGRAPHY X-RAY SYSTEM
K970606 · JAK
GE Medical Systems
Radiology · 45d
Cleared Apr 03, 1997
CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM
K962627 · LNI
Siemens Medical Solutions USA, Inc.
Radiology · 272d
Cleared Apr 03, 1997
ALOKA SSD-1700 DIAGNOSTIC ULTRASOUND SYSTEM
K963616 · IYN
Aloka Co., Ltd.
Radiology · 205d