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TIMS System

FDA UDI

Class II (US FDA UDI)

by Foresight Imaging, Llc

Identity

Trade Name
TIMS System FDA UDI
Generic Name
Radiology picture archiving and communication system workstation FDA UDI
Device Name
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. FDA UDI
Model / Reference
TIMS 2000 EN 51R FDA UDI
Description
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. FDA UDI

Identifiers

Catalog Number
061000-2000-EN FDA UDI
Primary DI / UDI-DI
00850059977255 FDA UDI
510(k) Number
K001947 FDA UDI
FDA Product Code
LLZ FDA UDI
GMDN Term
Radiology picture archiving and communication system workstation FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

TIMS System by Foresight Imaging, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K001947 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Foresight Imaging, Llc

Sources (1)

  • FDA UDI ae64f29b-88e0-4151-b07c-e8e854d5a1ed 36 fields · synced Jun 6, 2026