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
7993–8016 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
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
Cleared Sep 14, 2005
CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
K052325 · MUJ
Accuray Incorporated
Radiology · 20d
Cleared Sep 14, 2005
COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C
K052344 · LLZ
Eizo Nanao Corporation
Radiology · 19d
Cleared Sep 14, 2005
ADVANTAGE SIM MD
K052345 · KPQ
Ge Healthcare
Radiology · 19d
Cleared Sep 14, 2005
AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
K052355 · IYO
U-Systems, Inc.
Radiology · 16d
Cleared Sep 08, 2005
SOMATOM DEFINITION
K052216 · JAK
Siemens Medical Systems, Inc.
Radiology · 36d
Cleared Sep 08, 2005
SUPERDIMENSION/BRONCHUS 4.1
K052260 · JAK
Superdimension, Ltd.
Radiology · 20d
Cleared Sep 08, 2005
MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A
K052305 · LNH
Siemens Medical Solutions USA, Inc.
Radiology · 15d
Cleared Sep 08, 2005
MONOCHROME LCD MONITOR, MODEL RADIFORCE G33
K052337 · LLZ
Eizo Nanao Corporation
Radiology · 13d
Cleared Sep 07, 2005
NSTRAND IMPLANTATION KIT
K052024 · KXK
North American Scientific, Inc.
Radiology · 43d
Cleared Sep 07, 2005
ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES
K052078 · LNH
Philips Medical Systems Nederland B.V.
Radiology · 37d
Cleared Sep 07, 2005
AIDA COMPACT II SYSTEM
K052159 · LLZ
KARL STORZ Endoscopy-America, Inc.
Radiology · 29d
Cleared Sep 02, 2005
DAR-8000I
K052076 · IZI
Shimadzu Medical Systems
Radiology · 32d
Cleared Aug 31, 2005
DRYSTAR MODEL 5500
K052251 · LMC
Agfa Corporation
Radiology · 13d
Cleared Aug 29, 2005
DOPPLER GUIDED PROCTOSCOPE, MODEL 500H
K052067 · JAF
Multigon Industries, Inc.
Radiology · 28d
Cleared Aug 25, 2005
GR17 DIGITAL DETECTOR
K052136 · MQB
Anrad Corp.
Radiology · 20d
Cleared Aug 25, 2005
INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100,...
K052157 · JAK
Ge Medical Systems, LLC
Radiology · 17d
Cleared Aug 24, 2005
ACCESS BREAST COIL
K052045 · MOS
Confirma, Inc.
Radiology · 27d