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
5113–5136 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Mar 14, 2014
VOLCANO IFR MODALITY
K133323 · IYO
Volcano Corporation
Radiology · 136d
Cleared Mar 14, 2014
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING
K133227 · IYE
Varian Medical Systems, Inc.
Radiology · 144d
Cleared Mar 14, 2014
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION
K132944 · KPQ
Ge Hungary Kft
Radiology · 176d
Cleared Mar 11, 2014
BONE SUPPRESSION SOFTWARE
K133442 · MQB
Carestream Health, Inc.
Radiology · 119d
Cleared Mar 11, 2014
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL
K133401 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 125d
Cleared Mar 11, 2014
ACCURO 3000 ULTRASOUND SCANNER
K132736 · IYO
Rivanna Medical, LLC
Radiology · 189d
Cleared Mar 11, 2014
CIOS ALPHA
K132094 · OWB
Siemens Medi Cal Solutions, Inc.
Radiology · 246d
Cleared Mar 11, 2014
ISYS 1 (U.S),ACCESSORY, NON-STERILE
K131433 · JAK
Isys Medizintechnik GmbH
Radiology · 298d
Cleared Mar 07, 2014
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR...
K140291 · IYO
Volcano Corporation
Radiology · 30d
Cleared Mar 07, 2014
TABLE
K140093 · LLZ
Anatomage, Inc.
Radiology · 52d
Cleared Mar 07, 2014
IMPAX VOLUME VIEWING 3.0
K133135 · LLZ
Agfa Healthcare N.V.
Radiology · 154d
Cleared Mar 06, 2014
VENTRIPOINT MEDICAL SYSTEM
K140153 · IYN
Ventripoint, Inc.
Radiology · 43d
Cleared Mar 06, 2014
MODEL-BASED RSA SOFTWARE
K133966 · LLZ
Halifax Biomedical, Inc.
Radiology · 72d
Cleared Mar 06, 2014
ZEDVIEW
K133022 · LLZ
Lexi Co., Ltd.
Radiology · 161d
Cleared Mar 05, 2014
ALLURA XPER FD
K133292 · OWB
Philips Medical Systems Nederland B.V.
Radiology · 131d
Cleared Mar 04, 2014
SONIC WINDOW
K140126 · IYO
Analogic Corporation
Radiology · 47d
Cleared Mar 04, 2014
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE,...
K132908 · IYE
Medtec, Inc.
Radiology · 168d
Cleared Mar 03, 2014
HEARTSCAN SOFTWARE
K133937 · LLZ
Morpheus Imaging, Inc.
Radiology · 70d
Cleared Feb 28, 2014
SCENIUM
K133654 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 93d
Cleared Feb 28, 2014
THE DOME S6C
K133609 · LLZ
Nds Surgical Imaging
Radiology · 95d
Cleared Feb 28, 2014
ADVANCED VIEWER
K132763 · LLZ
Brainlab AG
Radiology · 177d
Cleared Feb 28, 2014
BIOMARC FIDUCIAL MARKER
K132064 · IYE
Carbon Medical Technologies, Inc.
Radiology · 240d
Cleared Feb 28, 2014
SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM
K131896 · LNH
Suzhou Anke Medical System Co., Ltd.
Radiology · 248d
Cleared Feb 28, 2014
HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM
K131777 · IWB
Hyper Technology, Inc.
Radiology · 256d