System, Image Processing, Radiological
FDA product code LLZ · 2150 cleared devices
Class 2
Radiology
- Regulation
- 21 CFR 892.2050
- Review panel
- RA
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1983-12-08 – 2026-09-23
LLZ
2010-12-03
LLZ
2010-11-23
ACCULMAING
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LLZ
2010-11-19
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)
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LLZ
2010-11-10
IMPROVIS IMAGING SYSTEM
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LLZ
2010-10-29
FULACCESS MODEL 1.0
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LLZ
2010-10-15
BEYONDIMAGE WORKSTATION
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LLZ
2010-10-12
IMAGYS
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LLZ
2010-10-07
VOLPARA, VERSION 1.3
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LLZ
2010-10-07
4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ
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LLZ
2010-10-05
SYNGO DYNAMICS, VERSION 9.0
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LLZ
2010-10-05
GE ECHOPAC MODEL BT10
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LLZ
2010-10-04
MIRADA RT
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LLZ
2010-10-01
XELIS DENTAL
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LLZ
2010-09-30
EP NAVIGATOR R3
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LLZ
2010-09-22
ENSITE VERISMO SEGMENTATION TOOL V.2.0
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LLZ
2010-09-22
UROSTATION 3D PROSTATE SUITE
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LLZ
2010-08-20
OSIRIX MD
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LLZ
2010-08-20
PROCEDURE REHEARSAL STUDIO
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LLZ
2010-08-17
CURIEPACS (DICOM PACS SOFTWARE)
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LLZ
2010-08-16
SYNGO TRUED SOFTWARE
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LLZ
2010-08-16
21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)
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LLZ
2010-08-10
SYNGO. PLAZA VA20A
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LLZ
2010-08-04
CORRIDOR4DM V2010 MODEL: V2010
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LLZ
2010-07-26
SYNAPSE 3D BASIC TOOLS
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LLZ
2010-07-26
MED-SEG, MODEL BTMS 1000
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LLZ
2010-07-15
PACSMATE MMD-5201M MONITOR
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LLZ
2010-06-23
MIRADA XD
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LLZ
2010-06-23
CORONIS FUSION 10MP, MODEL MDCG-10130
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LLZ
2010-06-23
CEDARA WEBACCESS, MODEL: 2.4
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LLZ
2010-05-07
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
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LLZ
2010-04-30
CAAS QVA 3D, CAAS QCA 3D
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LLZ
2010-04-30
ILUMA VISION MODEL VERSION 2.2
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LLZ
2010-04-14
SYNAPSE OBLIQUUS MIP/MPR/FUSION
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LLZ
2010-04-08
ORS VISUAL
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LLZ
2010-03-29
STAIR SYSTEMS PACS & DICOM VIEWER
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LLZ
2010-03-18
STORM-BASE 2.0
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LLZ
2010-03-18
SOFTVIEW, MODEL 2.01
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LLZ
2010-03-18
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW
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LLZ
2010-03-16
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)
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LLZ
2010-03-11
CARESTREAM IMAGE SUITE
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LLZ
2010-03-05
CUATTRO UNOMD
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LLZ
2010-03-05
STEREOS WORKSTATION
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LLZ
2010-03-04
SYNGO.PLAZA
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LLZ
2010-03-03
COLOR LCD MONITOR, MODEL RADIFORCE RS210
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LLZ
2010-03-01
ECHOPLAQUE
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LLZ
2010-02-23
SYNGO.PET&CT ONCOLOGY
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LLZ
2010-02-04
EXAPACS
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LLZ
2010-01-19
3DI
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LLZ
2010-01-08
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
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LLZ
2010-01-08
PCR ELEVA 1.2
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LLZ
2009-12-17
GALILEOS IMPLANT, VERSION 1.7
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LLZ
2009-12-11
AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION
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LLZ
2009-12-11
DIGITAL LIGHTBOX
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LLZ
2009-12-11
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4
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LLZ
2009-12-10
PRESIDIO PACS
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LLZ
2009-12-02
MEDSYNAPSE PACS SOFTWARE
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LLZ
2009-12-02
INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
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LLZ
2009-11-17
LUNGPOINT PROCEDURE PLANNING
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LLZ
2009-11-10
COLOR LCD MONITOR, MODEL RADIFORCE MX241W
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LLZ
2009-11-06
CADSTREAM VERSION 5
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LLZ
2009-10-30
INTEGRATED REGISTRATION
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LLZ
2009-10-30
MITS DICOM GATEWAY AND IMAGE MANAGER
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LLZ
2009-10-08
IMAGEGRID RADIOLOGY VIEWER SYSTEM
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LLZ
2009-10-08
PMD VIEWER
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LLZ
2009-09-18
ABVS WORKPLACE
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LLZ
2009-09-15
STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)
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LLZ
2009-08-27
SYNGO.X
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LLZ
2009-08-25
NORDICBRAINEX SOFTWARE, VERSION 1.0
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LLZ
2009-08-06
BEYONDIMAGE WORKSTATION
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LLZ
2009-07-21
QXLINK
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LLZ
2009-07-14
CORONIS 5MP HD, MODEL MDMG 5121
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LLZ
2009-07-07
PACSMATE, MODEL MMD-4300C/MMD-4300CX
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LLZ
2009-07-07
PACS PLUS 5TH EDITION
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LLZ
2009-06-29
MR CARDIAC FUNCTION ANALYSIS
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LLZ
2009-06-29
MYRIAN 1.4
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LLZ
2009-06-23
VISION TOOLS
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LLZ
2009-06-23
INTELEPACS, MODEL VERSION 3.X.X
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LLZ
2009-06-22
CERNER PROVISION WORKSTATION (VERSION 2.5)
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LLZ
2009-06-22
DEXIS SOFTWARE
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LLZ
2009-06-08
MODIFICATION TO NORDICICE SOFTWARE
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LLZ
2009-06-05
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE
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LLZ
2009-06-04
R2 DIGITALNOW HD(DIGITALNOW HD)
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LLZ
2009-05-22
IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0
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LLZ
2009-05-22
CAAS MR FLOW 1.0
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LLZ
2009-05-20
SYNGO TRUED
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LLZ
2009-05-18
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
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LLZ
2009-05-15
SYNGO US WORKPLACE
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LLZ
2009-05-12
SEGMENT
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LLZ
2009-05-05
NIO 2MP (MDNG-2121)
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LLZ
2009-05-05
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
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LLZ
2009-04-22
BLUE SKY BIO PLAN, VERSION .38
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LLZ
2009-04-22
BARCO 5MP MAMMO, MODEL MDMG-5221
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LLZ
2009-04-20
NIO COLOR 3MP AND MDNC-3121
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LLZ
2009-04-15
MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ
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LLZ
2009-04-15
MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL
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LLZ
2009-04-15
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER
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LLZ
2009-03-31
ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024
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LLZ
2009-03-31
CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING
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LLZ
2009-03-27
VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE
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LLZ
2009-03-23
BRIT PACS SYSTEMS
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