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
8041–8064 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Jul 01, 2005
DIRECT DIGITIZER REGIUS MODEL 370
K051418 · MQB
Konica Minolta Medical & Graphic, Inc.
Radiology · 30d
Cleared Jul 01, 2005
MICK HDR INTERSTITIAL IMPLANT ACCESSORIES
K051423 · JAQ
Mick Radio-Nuclear Instruments, Inc.
Radiology · 30d
Cleared Jul 01, 2005
GF-UE160-AL5 ULTRASOUND ENDOSCOPE
K051541 · FDF
Olympus America, Inc.
Radiology · 21d
Cleared Jun 29, 2005
BTI-SCAN, VERSION 4.0
K051392 · LLZ
B.T.I. Biotechnology Institute, Sl.
Radiology · 33d
Cleared Jun 28, 2005
OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
K050728 · MOS
Usa Instruments, Inc.
Radiology · 99d
Cleared Jun 28, 2005
IMAGEQUBE PACS
K051037 · LLZ
Intuitive Imaging Informatics, LLC
Radiology · 64d
Cleared Jun 28, 2005
CAC-127-8 CARDOAC ARRAY COIL
K051512 · MOS
Invivo Corp.
Radiology · 21d
Cleared Jun 28, 2005
REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION
K051521 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 20d
Cleared Jun 27, 2005
19-INCH (48 CM) COLOR LCD MONITOR CDL1902A
K051331 · LLZ
Totoku Electric Co., Ltd.
Radiology · 35d
Cleared Jun 24, 2005
PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL)
K051464 · EHD
Planmeca Oy
Radiology · 21d
Cleared Jun 23, 2005
3.0T PROSTATE IMAGING SYSTEM
K051349 · MOS
Medrad, Inc.
Radiology · 30d
Cleared Jun 21, 2005
KODAK DIRECTVIEW DR SYSTEM DETECTOR
K051483 · MQB
Eastman Kodak Company
Radiology · 15d
Cleared Jun 17, 2005
FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A
K051500 · IYO
Toshiba America Medical Systems, In.C
Radiology · 10d
Cleared Jun 16, 2005
GE VIVID 7 WITH OR WITHOUT SUFFIX
K051449 · IYN
GE Medical Systems
Radiology · 14d
Cleared Jun 15, 2005
MODIFICATION TO: SECTRA IDS5 WORKSTATION
K051315 · LLZ
Sectra-Imtec AB
Radiology · 26d
Cleared Jun 15, 2005
WEBPAX, MODEL 200
K051325 · LLZ
Heart Imaging Technologies, LLC
Radiology · 26d
Cleared Jun 15, 2005
C.CAM-AC
K051460 · KPS
Danish Diagnostic Development A/S
Radiology · 12d
Cleared Jun 13, 2005
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
K051402 · IYX
Gvi Technology Partners
Radiology · 13d
Cleared Jun 08, 2005
PRECEDENCE SPECT/CT IMAGING SYSTEM
K051351 · KPS
Adac Laboratories
Radiology · 15d
Cleared Jun 03, 2005
KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0
K051127 · LLZ
Kika Medical, Inc.
Radiology · 31d
Cleared Jun 03, 2005
ISCIENCE SURGICAL OPHTHALMIC IMAGING SYSTEM
K051304 · IYO
Science Surgical Corporation
Radiology · 15d
Cleared Jun 03, 2005
TERASON ULTRASOUND SYSTEM WITH CONTINUOUS WAVE SOPPLER
K051334 · IYN
Teratech Corp.
Radiology · 11d
Cleared Jun 01, 2005
DIGITAL RADIOGRAPHY SYSTEM RADSPEED SAFIRE
K050925 · MQB
Shimadzu Corp.
Radiology · 49d
Cleared Jun 01, 2005
GAMMAPLAN
K051022 · IWB
Elekta Instrument AB
Radiology · 40d