LLZ · Class II · 21 CFR 892.2050

FDA Product Code LLZ: System, Image Processing, Radiological

FDA product code LLZ covers radiological image processing systems.

These are software and hardware platforms that acquire, process, display, and archive medical images from modalities such as CT, MRI, X-ray, and ultrasound. They are used across radiology departments, surgical suites, and telemedicine platforms.

LLZ devices are Class II medical devices, regulated under 21 CFR 892.2050 and reviewed by the FDA Radiology panel.

Leading manufacturers include Siemens Medical Solutions USA, Inc., Totoku Electric Co., Ltd. and Barco N.V..

2280
Total
2280
Cleared
106d
Avg days
1983
Since
2280 devices
793–816 of 2280
Cleared Jun 21, 2011
QLAB 8.1 QUANTIFICATION SOFTWARE
K110414
Philips Ultrasound, Inc.
Radiology · 127d
Cleared May 24, 2011
EBW NM 2.0
K111336
Philips Medical Systems (Cleveland), Inc.
Radiology · 12d
Cleared May 20, 2011
SYNGO NEURO PBV-IR
K111052
Siemens Medical Solutions USA, Inc.
Radiology · 35d
Cleared May 05, 2011
CENTRICITY PACS
K110875
Ge Healthcare
Radiology · 36d
Cleared Apr 26, 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834
Ge Healthcare
Radiology · 32d
Cleared Apr 21, 2011
JETPACK 2.0
K111024
Philips Medical Systems (Cleveland), Inc.
Radiology · 9d
Cleared Apr 20, 2011
SYMBIA.NET
K110844
Siemens Medical Solutions USA, Inc.
Radiology · 23d
Cleared Apr 07, 2011
SYNAPSE 3D LIVER ANALYSIS
K110186
Fujifilm Medical System U.S.A., Inc.
Radiology · 76d
Cleared Apr 06, 2011
SYNGO MBF
K110494
Siemens Medical Solutions USA, Inc.
Radiology · 43d
Cleared Mar 16, 2011
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K103720
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 85d
Cleared Mar 07, 2011
THORACIC VCAR
K103480
Ge Medical Systems, LLC
Radiology · 101d
Cleared Mar 04, 2011
VIEWPOINT 6
K103458
Ge Healthcare
Radiology · 101d
Cleared Mar 04, 2011
SYNAPSE 3D CEREBRAL ANALYSIS
K103687
Fujifilm Medical System U.S.A., Inc.
Radiology · 77d
Cleared Mar 04, 2011
BARCO MAMMO TOMOSYNTHESIS
K103792
Barco N.V.
Radiology · 67d
Cleared Feb 02, 2011
SECURVIEW DX DIAGNOSTIC WORKSTATION
K103385
Hologic, Inc.
Radiology · 76d
Cleared Jan 31, 2011
SYNAPSE 3D CARDIAC TOOLS
K103465
Fujifilm Medical Systems U.S.A, Inc.
Radiology · 68d
Cleared Jan 25, 2011
Q-STATION
K103815
Philips Ultrasound, Inc.
Radiology · 27d
Cleared Nov 19, 2010
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
K092728
Totoku Electric Co., Ltd.
Radiology · 441d
Cleared Oct 07, 2010
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
K101166
Ge Healthcare
Radiology · 164d
Cleared Oct 05, 2010
SYNGO DYNAMICS, VERSION 9.0
K102150
Siemens Medical Solutions USA, Inc.
Radiology · 68d
Cleared Sep 22, 2010
ENSITE VERISMO SEGMENTATION TOOL V.2.0
K101697
St Jude Medical
Radiology · 98d
Cleared Aug 16, 2010
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
K090947
Totoku Electric Co., Ltd.
Radiology · 500d
Cleared Jul 26, 2010
SYNAPSE 3D BASIC TOOLS
K101662
Fujifilm Medical System U.S.A., Inc.
Radiology · 42d
Cleared Jun 23, 2010
CORONIS FUSION 10MP, MODEL MDCG-10130
K093197
Barco N.V.
Radiology · 257d