TIMS System 061000-2000-EN

GUDID 00850059977118

TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, DICOM send and receive, CD/DVD/USB burning.

FORESIGHT IMAGING, LLC

Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation Radiology picture archiving and communication system workstation

Primary Device ID	00850059977118
NIH Device Record Key	185b7710-4943-4a6b-b42d-4df66b33f471
Commercial Distribution Status	In Commercial Distribution
Brand Name	TIMS System
Version Model Number	TIMS 2000 EN 50P
Catalog Number	061000-2000-EN
Company DUNS	144124518
Company Name	FORESIGHT IMAGING, LLC
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850059977118 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K001947

FDA Product Code

LLZ	System, Image Processing, Radiological

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-05-06
Device Publish Date	2024-04-26

On-Brand Devices [TIMS System]

00850951007197	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007180	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007173	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007166	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007159	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007142	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007135	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007128	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007111	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007104	TIMS System connects to all analog and digital modalities. Usage includes video and image acqui
00850951007098	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007081	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007074	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007036	TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Inter
00850951007029	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007012	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007005	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007227	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007210	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007203	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007272	TIMS System connects to all analog and digital modalities. Usage includes video and image acqui
00850951007265	TIMS Streamer transmits any live medical modality video over networks - LAN, WAN, VPN, and Inter
00850951007258	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007241	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007234	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007333	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007326	TIMS 2000 connects to all analog and DICOM medical modalities. Functionality includes static im
00850951007319	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007302	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007296	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007289	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007364	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007357	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007340	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007395	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007388	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007371	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007425	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007418	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007401	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007456	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007449	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007432	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007487	TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static ima
00850951007470	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007463	TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static
00850951007524	TIMS 2000 EN connects to all analog and DICOM medical modalities. Functionality includes static
00850951007517	TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality in
00850951007500	TIMS 2000 FEES connects to all analog, digital and DICOM medical modalities. Functionality incl
00850951007494	TIMS 500 S connects to all analog, digital and DICOM medical modalities. Functionality includes