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
7945–7968 of 15,589
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Oct 04, 2005
3T HD BREAST ARRAY
K052585 · MOS
Usa Instruments, Inc.
Radiology · 14d
Cleared Sep 30, 2005
IPLAN RT FIBERTRACKING
K052220 · IYE
Brainlab AG
Radiology · 46d
Cleared Sep 30, 2005
COLOR CORONIS 2MP-21 AND MFCD 2321
K052352 · LLZ
Barcoview
Radiology · 32d
Cleared Sep 30, 2005
E-2320 PA S
K052529 · LLZ
Barcoview
Radiology · 16d
Cleared Sep 29, 2005
SITE-RITE 5 ULTRASOUND SYSTEM
K052517 · ITX
C.R. Bard, Inc.
Radiology · 15d
Cleared Sep 28, 2005
MFCD 1219, MFCD 1219 TS
K052478 · LLZ
Barcoview
Radiology · 19d
Cleared Sep 27, 2005
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
K052172 · LNH
Hitachi Medical Systems America, Inc.
Radiology · 49d
Cleared Sep 27, 2005
THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE)
K052422 · EAP
Flow X-Ray Corp.
Radiology · 25d
Cleared Sep 27, 2005
HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA
K052434 · KPS
GE Medical Systems
Radiology · 21d
Cleared Sep 27, 2005
PORTAL GRAVITY SYSTEM
K052579 · LNH
Portal, Inc.
Radiology · 7d
Cleared Sep 22, 2005
21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
K052199 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Sep 22, 2005
SIMTEC IM-MAXX 2 OPTION
K052315 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 28d
Cleared Sep 22, 2005
ACUSON SEQUOIA ULTRASOUND SYSTEM
K052410 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 20d
Cleared Sep 22, 2005
SYNGO IMAGING VERSION V20A
K052461 · LLZ
Siemens AG Medical Solutions
Radiology · 14d
Cleared Sep 21, 2005
MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001
K051494 · MQB
Cr Tech, Ltd.
Radiology · 107d
Cleared Sep 21, 2005
NIO 2MP-20 AND E-2620 S
K052276 · LLZ
Barcoview
Radiology · 30d
Cleared Sep 21, 2005
GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM
K052293 · LNH
Ge Medical Systems, LLC
Radiology · 29d
Cleared Sep 21, 2005
HIPAX MEDICAL IMAGING SOFTWARE
K052411 · LLZ
Steinhart Medizinsysteme GmbH
Radiology · 23d
Cleared Sep 21, 2005
GE LOGIQ 7 ULTRASOUND BT05
K052441 · IYN
General Electric Co.
Radiology · 15d
Cleared Sep 21, 2005
SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600
K052447 · JAK
Analogic Corp.
Radiology · 14d
Cleared Sep 21, 2005
POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE
K052460 · LLZ
Ramsoft, Inc.
Radiology · 14d
Cleared Sep 16, 2005
INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ
K052412 · OWB
Ge Healthcare
Radiology · 14d
Cleared Sep 15, 2005
CORONIS 2MP-21 AND MFGD 2621
K052403 · LLZ
Barcoview
Radiology · 14d
Cleared Sep 15, 2005
CORONIS 3MP-21 AND MFGD 3621
K052429 · LLZ
Barcoview
Radiology · 9d