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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 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. FDA UDI
Model / Reference
TIMS 500 35M FDA UDI
Description
TIMS 500 connects to all analog and DICOM medical modalities. Functionality includes static image capture and DICOM send and receive. FDA UDI

Identifiers

Catalog Number
061000-500 FDA UDI
Primary DI / UDI-DI
00850951007289 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 25d969ba-2fca-406b-8f78-b26f0bc37dc2 36 fields · synced May 30, 2026