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
7921–7944 of 15,620
Search insights Median review: 80d Cleared: 100% Top manufacturer: Siemens Medical Solutions USA, Inc. Lead specialty: Radiology
Cleared Nov 22, 2005
VISTADENT AT COMPLETE, MODEL 3.1
K053010 · LLZ
Dentsply Intl., Inc.
Radiology · 27d
Cleared Nov 18, 2005
ENCOMPASS SOFTWARE PACKAGE
K053043 · LLZ
Toshiba America Medical Systems, In.C
Radiology · 21d
Cleared Nov 17, 2005
IMAGECAST PACS
K052618 · LLZ
Idx Systems Corp.
Radiology · 55d
Cleared Nov 17, 2005
CR-PRO
K052938 · MQB
Eradlink, Inc.
Radiology · 28d
Cleared Nov 17, 2005
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K053009 · LNH
GE Medical Systems
Radiology · 22d
Cleared Nov 17, 2005
MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE
K053042 · MOS
Medrad, Inc.
Radiology · 20d
Cleared Nov 16, 2005
CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0
K052537 · LLZ
American Medical Sales, Inc.
Radiology · 62d
Cleared Nov 16, 2005
COLOR NIO 2MP, E-2320 C
K052958 · LLZ
Barcoview
Radiology · 26d
Cleared Nov 16, 2005
MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS
K053017 · MOS
Invivo Corporation
Radiology · 21d
Cleared Nov 16, 2005
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
K053069 · IYN
Sonosite,Inc.
Radiology · 15d
Cleared Nov 16, 2005
SIGMA 5000 SERIES IMAGIC ULTRASOUND SYSTEM
K053084 · IYN
Kontron Medical Systems Sas
Radiology · 14d
Cleared Nov 14, 2005
SUPERDIMENSION/BRONCHUS PREMIUM
K052852 · JAK
Superdimension, Ltd.
Radiology · 34d
Cleared Nov 10, 2005
ACUSON CYPRESS ULTRASOUND SYSTEM
K052331 · IYN
Siemens Medical Solutions USA, Inc.
Radiology · 76d
Cleared Nov 09, 2005
SMIT SLEEVE
K052228 · JAQ
Nucletron Corporation
Radiology · 85d
Cleared Nov 09, 2005
USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY
K052916 · MOS
Usa Instruments, Inc.
Radiology · 23d
Cleared Nov 09, 2005
GE 1.5T SIGNA HDE MR SYSTEM
K052978 · LNH
Ge Medical Systems, LLC
Radiology · 16d
Cleared Nov 08, 2005
INFINITT G3 PACS
K052545 · LLZ
Infinitt Co., Ltd.
Radiology · 54d
Cleared Nov 08, 2005
CRC 15ULTRA
K052595 · JAQ
Capintec, Inc.
Radiology · 48d
Cleared Nov 08, 2005
MODIFICATION TO: AURORA
K052698 · LNH
Aurora Imaging Technology, Inc.
Radiology · 41d
Cleared Nov 08, 2005
GE DEFINIUM AMX 700, MODEL AMX 700
K052897 · IZL
General Electric Medical Systems
Radiology · 25d
Cleared Nov 08, 2005
BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI...
K052987 · LNH
Noras Rontgen-Und Medizintechnik GmbH
Radiology · 15d
Cleared Nov 08, 2005
ADVANTAGE WORKSTATION 4.3.
K052995 · LLZ
Ge Healthcare
Radiology · 14d
Cleared Nov 08, 2005
ILUMA ORTHOCAT/DENTALCAT
K053046 · JAK
Imtec Corp.
Radiology · 11d
Cleared Nov 04, 2005
SYNGO NEURO DSA CT
K053024 · JAK
Siemens AG
Radiology · 14d