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
8545–8568 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 09, 2004
TELETHERMOGRAPHIC CAMERA, SERIES A, E, S AND P
K033967 · LHQ
Flir Systems
Radiology · 78d
Cleared Mar 09, 2004
SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE
K034059 · LLZ
Sectra AB
Radiology · 69d
Cleared Mar 09, 2004
SIREMOBIL ISO-C 3D
K040347 · OXO
Siemens Medical Systems, Inc.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL
K040348 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
MODIFICATION TO HRW-127 WRIST ARRAY COIL
K040349 · MOS
Mri Devices Corp.
Radiology · 26d
Cleared Mar 09, 2004
SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS
K040502 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 11d
Cleared Mar 05, 2004
QSC-127-INT SHOULDER ARRAY COIL SET
K040288 · MOS
Mri Devices Corp.
Radiology · 28d
Cleared Mar 02, 2004
CT-MASS
K033774 · JAK
Medis Medical Imaging Systems BV
Radiology · 90d
Cleared Mar 01, 2004
LIGHTSPEED 7.0 CT SCANNER SYSTEM
K040372 · JAK
Ge Medical Systems, LLC
Radiology · 13d
Cleared Feb 27, 2004
ON-BOARD IMAGER DEVICE
K040192 · IYE
Varian Medical Systems, Inc.
Radiology · 30d
Cleared Feb 27, 2004
LARSEN & TOUBRO LIMITED SENORITA COLOR DOPPLER ULTRASOUND SYSTEM
K040409 · IYN
Larsen & Toubro Limited
Radiology · 9d
Cleared Feb 26, 2004
3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
K032555 · LLZ
Totoku Electric Co., Ltd.
Radiology · 191d
Cleared Feb 25, 2004
AUTOQUANT PLUS
K040326 · KPS
Adac Laboratories
Radiology · 15d
Cleared Feb 24, 2004
ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER
K033650 · OBJ
Siemens Medical Solutions USA, Inc.
Radiology · 96d
Cleared Feb 24, 2004
VITREA2 VERSION 3.5
K040305 · LLZ
Vital Images, Inc.
Radiology · 15d
Cleared Feb 20, 2004
INFRARED SCIENCES BREASTSCAN IR SYSTEM
K032350 · LHQ
Infrared Sciences Corp.
Radiology · 205d
Cleared Feb 20, 2004
DIGITAL ANGIOGRAPHY SYSTEM DIGITEX SAFIRE
K032443 · IZI
Shimadzu Corp.
Radiology · 196d
Cleared Feb 20, 2004
COLOR LCD DISPLAY, MODEL RADIFORCE R22
K033466 · LLZ
Eizo Nanao Corporation
Radiology · 112d
Cleared Feb 20, 2004
BRAIN PERFUSION OPTION
K033677 · JAK
Philips Medical Systems (Cleveland),...
Radiology · 88d
Cleared Feb 20, 2004
TROPHYPAN AND TROPHYPAN C
K033690 · EHD
Trophy Radiologie
Radiology · 88d
Cleared Feb 20, 2004
KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY
K033821 · LMC
Eastman Kodak Company
Radiology · 73d
Cleared Feb 20, 2004
PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
K034054 · JAI
Med-Tec,Inc.
Radiology · 52d
Cleared Feb 20, 2004
GE LOGIQ 9 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 2404587
K040251 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 17d
Cleared Feb 19, 2004
INTEGRIS 3D-RA, RELEASE 4.2
K040254 · LLZ
Philips Medical Systems North America...
Radiology · 15d