TIMS System - TIMS 2000 SP connects to all analog and DICOM - FORESIGHT IMAGING, LLC

Duns Number:144124518

Device Description: TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes TIMS 2000 SP connects to all analog and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning.

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More Product Details

Catalog Number

061000-2000-SP

Brand Name

TIMS System

Version/Model Number

TIMS 2000 SP 35M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K001947

Product Code Details

Product Code

LLZ

Product Code Name

System, Image Processing, Radiological

Device Record Status

Public Device Record Key

51cfb81e-2955-4ba4-afef-6fb1b9f91899

Public Version Date

January 08, 2021

Public Version Number

1

DI Record Publish Date

December 31, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORESIGHT IMAGING, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 58