FDA.reportPublic FDA data

TIMS System

Primary DI
00850059977552
Brand
TIMS System
Company
FORESIGHT IMAGING, LLC
Model
TIMS 2000 EN 55T
Catalog number
061000-2000-EN
Device 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.
Published
2026-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K001947000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001947000T.I.M.S., VERSION 2.00Total Medical Information Management Systems, Inc.2000-11-22LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850059977552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059977552008500599775528500599775520850059977552

GMDN Terms#

Term, Definition table
TermDefinition
Radiology picture archiving and communication system workstationA freestanding, image processing device that is a component of a picture archiving and communication system (PACS) for radiology designed to be networked with a wide variety of diagnostic imaging systems [e.g., x-ray, nuclear medicine, magnetic resonance imaging (MRI) or ultrasound (US), as well as a laboratory or hospital information system (HIS)]. It does not contain controls for the direct operation of a diagnostic imaging system and is designed to receive, archive, and transmit data both on-line and off-line. It is configured to provide limited or extensive capabilities to further process, manipulate and/or view patient images and information collected from diagnostic imaging systems.

Regulatory Flags#

DUNS number
144124518
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059977576TIMS SystemTIMS 500 S 56T061000-5002026-07-03
00850059977583TIMS SystemTIMS 2000 FEES 56T061000-FEES2026-07-03
00850059977590TIMS SystemTIMS 2000 FEES-L 56T061000-FEES-L2026-07-03
00850059977606TIMS SystemTIMS 2000 EN 56T061000-2000-EN2026-07-03
00850059977613TIMS SystemTIMS 2000 SP 56T061000-2000-SP2026-07-03
00850059977521TIMS SystemTIMS 500 S 55T061000-5002026-06-26
00850059977538TIMS SystemTIMS 2000 FEES 55T061000-FEES2026-06-26
00850059977545TIMS SystemTIMS 2000 FEES-L 55T061000-FEES-L2026-06-26
00850059977569TIMS SystemTIMS 2000 SP 55T061000-2000-SP2026-06-26
00850059977422TIMS SystemTIMS 2000 FEES 53T061000-FEES2025-10-06
00850059977439TIMS SystemTIMS 2000 FEES-L 53T061000-FEES-L2025-10-06
00850059977446TIMS SystemTIMS 2000 EN 53T061000-2000-EN2025-10-06
00850059977453TIMS SystemTIMS 500 S 53T061000-5002025-10-06
00850059977460TIMS SystemTIMS 2000 SP 53T061000-2000-SP2025-10-06
00850059977477TIMS SystemTIMS 2000 SP 54T061000-2000-SP2026-04-17
00850059977484TIMS SystemTIMS 500 S 54T061000-5002026-04-17
00850059977491TIMS SystemTIMS 2000 EN 54T061000-2000-EN2026-04-17
00850059977507TIMS SystemTIMS 2000 FEES-L 54T061000-FEES-L2026-04-17
00850059977514TIMS SystemTIMS 2000 FEES 54T061000-FEES2026-04-17
00850059977378TIMS SystemTIMS 2000 FEES 53S061000-FEES2025-05-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
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00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
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