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
2009-03-19
LLZ
2009-03-16
UROCARE
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LLZ
2009-03-13
LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM
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LLZ
2009-03-04
BODYVIZ, MODEL 100
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LLZ
2009-03-04
DATACOM DC PACS
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LLZ
2009-02-25
BONEVUE
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LLZ
2009-02-25
VISIX IMAGING
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LLZ
2009-02-23
RESOLUTIONMD, RELEASE 2.1
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LLZ
2009-02-19
NEUROSCAPE
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LLZ
2009-02-13
MAMMODIAGNOST VU
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LLZ
2009-02-05
SICAT IMPLANT
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LLZ
2009-02-02
CADSTREAM, VERSION 5.0
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LLZ
2009-01-28
COLOR LCD MONITOR, RADIFORCE RX320
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LLZ
2009-01-28
PACS SCAN
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LLZ
2009-01-14
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD
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LLZ
2009-01-14
ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
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LLZ
2009-01-13
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG
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LLZ
2009-01-09
MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK
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LLZ
2009-01-09
IMAGESVR PACS
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LLZ
2009-01-05
CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)
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LLZ
2008-12-30
CARESTREAM PACS, MODEL CARESTREAM PACS VII
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LLZ
2008-12-23
IMAGE-ARENA APPLICATIONS
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LLZ
2008-12-19
CT BRAIN PERFUSION FOR ZIOSTATION
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LLZ
2008-12-16
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION
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LLZ
2008-12-12
VISAGE PACS, VERSION 6.0/CS 3.1
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LLZ
2008-12-05
MRI-PLAQUE VIEW, VERSION 1.1.2003
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LLZ
2008-11-21
NORDICICE SOFTWARE
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LLZ
2008-11-20
INFINITT XELIS
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LLZ
2008-11-20
CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23
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LLZ
2008-11-20
SNTRYPACS
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LLZ
2008-11-14
CENTRICITY PACS WEB DIAGNOSTIC
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LLZ
2008-11-14
SYNGO IMAGING XS
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LLZ
2008-11-06
INFINITT CARDIOLOGY PACS
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LLZ
2008-10-23
MEDICAL DISPLAY, MD205MG-1
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LLZ
2008-10-21
SHOWCASE
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LLZ
2008-10-15
XR-EXPRESS
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LLZ
2008-10-14
4D VIEWER RADIOLOGY, MODEL USWP-100A
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LLZ
2008-10-06
COLOR LCD MONITOR
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LLZ
2008-10-01
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
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LLZ
2008-09-26
UNISYN IMAGE FUSION, VERSION 1.0
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LLZ
2008-09-25
AW SERVER
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LLZ
2008-09-23
ULTRAEXTEND USWS-900A
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LLZ
2008-09-22
PLANISIGHT LINASYS
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LLZ
2008-09-19
RAYPAX SYSTEM
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LLZ
2008-09-17
SPY ANALYSIS TOOLKIT, MODEL SA9000
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LLZ
2008-09-16
INREACH PLANNING LAPTOP
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LLZ
2008-09-12
QUANTRA
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LLZ
2008-09-12
21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)
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LLZ
2008-09-10
VISUALASE THERMAL THERAPY SYSTEM
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LLZ
2008-09-09
PACSMATE MMD-3213M MONITOR
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LLZ
2008-09-05
AMICAS PACS, VERSION 6.0
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LLZ
2008-09-05
5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)
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LLZ
2008-09-05
Z3D CONTRAST ACUITY
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LLZ
2008-08-29
DSA 2000EX
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LLZ
2008-08-29
STEREOS WORKSTATION
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LLZ
2008-08-26
VOLUMINA
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LLZ
2008-08-25
CENTRICITY PACS IW
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LLZ
2008-08-15
C-INSIGHT
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LLZ
2008-08-06
EDGE PACS
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LLZ
2008-08-01
FIATLUX VISUALIZE
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LLZ
2008-07-29
MAMMO WORKSTATION
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LLZ
2008-07-28
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
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LLZ
2008-07-18
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
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LLZ
2008-07-18
SIMPLANT ORTHO ; VISTADENT 3D
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LLZ
2008-07-16
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
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LLZ
2008-07-15
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
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LLZ
2008-07-03
SYNGO IMAGING (VERSION V31)
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LLZ
2008-06-20
VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE
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LLZ
2008-06-17
DC NEURO
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LLZ
2008-06-12
SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2
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LLZ
2008-06-11
ALZ WEB PACS, VERSION 1.0
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LLZ
2008-06-11
21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
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LLZ
2008-06-04
FUJIFILM FCR VIEW, MODEL CR-VW674
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LLZ
2008-06-04
21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)
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LLZ
2008-06-04
21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)
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LLZ
2008-05-29
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A
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LLZ
2008-05-29
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A
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LLZ
2008-05-28
ILUMA VISION
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LLZ
2008-05-16
BI-RADS COMPANION
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LLZ
2008-05-02
CORONIS 5MP MAMMO SL, MODEL MDMG 6121
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LLZ
2008-05-01
3-D IMAGING WORKSTATION
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LLZ
2008-04-29
SMARTSPOT PRIMAX
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LLZ
2008-04-25
SYNGO DYNAMICS VERSION 7.0
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LLZ
2008-04-25
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A
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LLZ
2008-04-22
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI
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LLZ
2008-04-22
SYNGO MULTIMODALITY WORKPLACE
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LLZ
2008-04-18
NM APPLICATION SUITE
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LLZ
2008-04-17
DIGITAL LIGHTBOX
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LLZ
2008-04-16
SURGICASE
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LLZ
2008-04-09
IMAGENMD WITH IMAGENQ
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LLZ
2008-04-08
IGROK
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LLZ
2008-04-02
MIMICS
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LLZ
2008-03-20
COLOR LCD MONITOR, MODEL RADIFORCE RX211
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LLZ
2008-03-19
TRAUMACAD VERSION 2.0
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LLZ
2008-03-19
KANTERON DICOM STATION (KDS), MODEL 3.0
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LLZ
2008-03-12
AMICAS VISION SERIES PACS, MODEL 5.5
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LLZ
2008-03-10
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520
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LLZ
2008-03-10
OMNI-VUE SYSTEM
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LLZ
2008-02-29
SYNGO IMAGING CCF VA10A
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LLZ
2008-02-22
IMAGEGRID
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