FDA.reportPublic FDA data

TIMS System

Primary DI
00850059977507
Brand
TIMS System
Company
FORESIGHT IMAGING, LLC
Model
TIMS 2000 FEES-L 54T
Catalog number
061000-FEES-L
Device description
TIMS 2000 FEES-L connects to all analog, digital and DICOM medical modalities. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
Published
2026-04-17
Public version status
New
Distribution status
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
00850059977507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059977507008500599775078500599775070850059977507

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
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00850059977514TIMS SystemTIMS 2000 FEES 54T061000-FEES2026-04-17
00850059977279TIMS SystemTIMS 2000 SP 52S061000-2000-SP2025-02-07
00850059977286TIMS SystemTIMS 500 S 52S061000-5002025-02-07
00850059977293TIMS SystemTIMS 2000 EN 52S061000-2000-EN2025-02-07
00850059977309TIMS SystemTIMS 2000 FEES 52S061000-FEES2025-02-07
00850059977316TIMS SystemTIMS 2000 FEES-L 52S061000-FEES-L2025-02-07
00850059977323TIMS SystemTIMS 2000 FEES 52R061000-FEES2025-02-07
00850059977330TIMS SystemTIMS 2000 FEES-L 52R061000-FEES-L2025-02-07
00850059977347TIMS SystemTIMS 2000 EN 52R061000-2000-EN2025-02-07
00850059977354TIMS SystemTIMS 500 S 52R061000-5002025-02-07
00850059977361TIMS SystemTIMS 2000 SP 52R061000-2000-SP2025-02-07
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
00850059977378TIMS SystemTIMS 2000 FEES 53S061000-FEES2025-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
M722CD26103V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-04-20
M722CP26104V261040ClearRead CT Platform DockerRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.LLZ2026-02-24
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.LLZ2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.LLZ2026-01-28