FDA.reportPublic FDA data

TIMS System

Primary DI
00850059977279
Brand
TIMS System
Company
FORESIGHT IMAGING, LLC
Model
TIMS 2000 SP 52S
Catalog number
061000-2000-SP
Device description
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.
Published
2025-02-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00850059977279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059977279008500599772798500599772790850059977279

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144124518
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850059977637TIMS SystemTIMS 500 S 57T061000-5002026-08-07
00850059977644TIMS SystemTIMS 2000 EN 57T061000-2000-EN2026-08-07
00850059977651TIMS SystemTIMS 2000 FEES 57T061000-FEES2026-08-07
00850059977668TIMS SystemTIMS 2000 FEES-L 57T061000-FEES-L2026-08-07
00850059977675TIMS SystemTIMS 2000 SP 57T061000-2000-SP2026-08-07
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
00850059977552TIMS SystemTIMS 2000 EN 55T061000-2000-EN2026-06-26
00850059977569TIMS SystemTIMS 2000 SP 55T061000-2000-SP2026-06-26
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260456230215CHILI PACSCHILI GmbHLLZ2026-09-25
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00850025268431Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-09-21
08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
00817886020677JointsMEDSTRAT, INC.LLZ2026-02-16
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00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
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00817886020554JointsMEDSTRAT, INC.LLZ2023-11-13
00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
00754016387111ANDIImeka Solutions IncLLZ2023-09-01
00817886020516JointsMEDSTRAT, INC.LLZ2023-05-29
00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03