FDA.reportPublic FDA data

TIMS System

Primary DI
00850951007258
Brand
TIMS System
Company
FORESIGHT IMAGING, LLC
Model
TIMS 2000 SP 32L
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
2019-04-12
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
00850951007258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850951007258008509510072588509510072580850951007258

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
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
00850059977552TIMS SystemTIMS 2000 EN 55T061000-2000-EN2026-06-26
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G874AVARAVIEWER0010Avara ViewerAVARA SOFTWARE LLCLLZ2026-07-13
06938396401528SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401559SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401566SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401597SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401603SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401634SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401658SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401702SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396401719SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
06938396410124SIUIShantou Institute of Ultrasonic Instruments Co., Ltd.LLZ2026-07-10
04260483290305MeVis AVM ContourMeVis Medical Solutions AGLLZ2026-07-09
G775EVOLVE4140EVOLVESmaart Medical Systems, Inc.LLZ2026-07-09
080563044562053mensio WorkstationPie Medical Imaging B.V.LLZ2026-07-08
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977583TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977521TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977538TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977545TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977552TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00850059977569TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-06-26
00889024673403NavitrackER®Orthosoft IncLLZ2026-06-26
00889024699762ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699779ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699786ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699793ROSA® ShoulderOrthosoft IncLLZ2026-06-26
00889024699809ROSA® ShoulderOrthosoft IncLLZ2026-06-26