FDA.reportPublic FDA data

TIMS System

Primary DI
00850059977583
Brand
TIMS System
Company
FORESIGHT IMAGING, LLC
Model
TIMS 2000 FEES 56T
Catalog number
061000-FEES
Device description
TIMS 2000 FEES 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
2026-07-03
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
00850059977583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850059977583008500599775838500599775830850059977583

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
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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850059977576TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977590TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977606TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00850059977613TIMS SystemFORESIGHT IMAGING, LLCLLZ2026-07-03
00628184004500Intellijoint VIEWIntellijoint Surgical IncLLZ2026-06-09
00860005144082Brain AgeDeephealth, Inc.LLZ2026-06-08
07649997938038Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
07649997938052Swissmeda Dental Planning SystemSwissmeda AGLLZ2026-06-08
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LLZ2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLLZ2026-06-05
08437021468212QP-ProstateQUIBIM SOCIEDAD LIMITADA.LLZ2026-06-05
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
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
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03