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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Radiology ×
15,589 results
8617–8640 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 10, 2003
TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS
K033418 · JAK
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Nov 07, 2003
DGH 55 HANDHELD PACHYMETER (PACHMATE)
K033385 · IYO
Dgh Technology, Inc.
Radiology · 15d
Cleared Nov 06, 2003
LUNGCARE CT SOFTWARE PACKAGE WITH EXTENDED FUNCTIONALITY
K033374 · OEB
Siemens AG Medical Solutions
Radiology · 15d
Cleared Nov 05, 2003
ECHOCONNEX COMMUNICATOR
K033093 · LLZ
Connexmd
Radiology · 37d
Cleared Nov 05, 2003
MEDIC COLON MODEL, RELEASE 1
K033102 · JAK
Medicsight
Radiology · 37d
Cleared Nov 05, 2003
HOLOGIC QDR EXPLORER X-RAY BONE DENSITOMETER, MODEL EXPLORER
K033224 · KGI
Hologic, Inc.
Radiology · 30d
Cleared Nov 05, 2003
VIATRONIX V3D VASCULAR, REVISION 1.0
K033361 · LLZ
Viatronix, Inc.
Radiology · 15d
Cleared Nov 05, 2003
TITAN ULTRASOUND SYSTEM, SONOSITE ILOOK 25 ULTRASOUND SYSTEM, 180PLUS...
K033367 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Oct 31, 2003
FUKUDA DENSHI MODEL FF SONIC UF-750XT
K033209 · IYN
Fukuda Denshi USA, Inc.
Radiology · 28d
Cleared Oct 30, 2003
RATIONAL IMAGING PACS
K031473 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 174d
Cleared Oct 30, 2003
GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X
K032656 · IYN
Ge Med. Systems Ultrasound & Prim....
Radiology · 63d
Cleared Oct 30, 2003
ADVANTAGE 4D OPTION
K032915 · JAK
Ge Medical Systems, LLC
Radiology · 38d
Cleared Oct 29, 2003
VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE
K032748 · LLZ
Vital Images, Inc.
Radiology · 54d
Cleared Oct 29, 2003
SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1
K033088 · LLZ
Sectra AB
Radiology · 30d
Cleared Oct 29, 2003
ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM
K033311 · IYN
Aloka Co., Ltd.
Radiology · 15d
Cleared Oct 29, 2003
SUPEROPEN 0.23T, MODEL NAM-P023A
K033315 · LNH
Neusoft Digital Medical Systems Co.,...
Radiology · 14d
Cleared Oct 29, 2003
PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM
K033326 · JAK
Philips Medical Systems, Inc.
Radiology · 13d
Cleared Oct 23, 2003
BIOPSY BREAST COIL, MODEL BBC
K032576 · MOS
Mri Devices Corp.
Radiology · 64d
Cleared Oct 23, 2003
ELEKTA SYNERGY SYSTEM
K032996 · IYE
Elekta Oncology Systems, Ltd.
Radiology · 28d
Cleared Oct 23, 2003
GE MARLIN ULTRASOUND
K033139 · IYN
General Electric Co.
Radiology · 23d
Cleared Oct 22, 2003
GE LOGIQ BOOK
K032477 · IYN
General Electric Co.
Radiology · 71d
Cleared Oct 22, 2003
FORTE GAMMA CAMERA SYSTEM
K033254 · KPS
Adac Laboratories
Radiology · 14d
Cleared Oct 21, 2003
GE LOGIQ 5 PRO OR EXPERT
K032974 · IYN
General Electric Co.
Radiology · 27d
Cleared Oct 20, 2003
HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM
K033248 · MUH
Hitachi Medical Systems America, Inc.
Radiology · 13d