FDA.reportPublic FDA data

Digi-Lite IP Linear Probe

Primary DI
07290016734034
Brand
Digi-Lite IP Linear Probe
Company
RIMED LTD.
Model
Digi-Lite IP Linear Probe
Catalog number
400002
Device description
The Digi-Lite IP Linear Probe is an ultrasonic transducer which generate acoustic signals and also detect returned signals and intended to be used in combination with the Digi-Lite to enable it to perform a medical purpose
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113184000LOGICSCAN 64 LOGICSCAN 128Telemed2012-01-26IYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290016734034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290016734034072900167340347290016734034

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
600054688
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290016734003Digi-LiteDigi-Lite2016-09-24
07290016734010Digi-Lite IPDigi-Lite IP4000012016-09-24
07290016734027Digi-One Digi-One2016-09-24
07290016734041PW 2MHz Ultrasonic ProbePW 2MHz Ultrasonic Probe23-6372016-09-24
07290016734058CW 4MHz Ultrasonic ProbeCW 4MHz Ultrasonic Probe23-6362016-09-24
07290016734065CW 8MHz Ultrasonic ProbeCW 8MHz Ultrasonic Probe23-6352016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841517112653rP19x/5-1 MHz ArmoredFUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112660L12-3FUJIFILM SONOSITE, INC.ITX2026-06-24
00841517112677L15-4FUJIFILM SONOSITE, INC.ITX2026-06-24
00852619008041QT Scanner 2000Qt Imaging, Inc.ITX2026-06-24
00841517112646L15-4FUJIFILM SONOSITE, INC.ITX2026-06-23
00841517112639L12-3FUJIFILM SONOSITE, INC.ITX2026-06-22
00198953078716LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953078754LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147009LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147016LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00198953147351LOGIQGE Medical Systems (China) Co.,Ltd.ITX2026-06-10
00850050934233EndoSound® EVS ProbeEndosound, Inc.ITX2026-06-01
04987670105937DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
04987670106194DIAGNOSTIC ULTRASOUND SYSTEMCANON INC.ITX2026-06-01
08800013510112L8-17HAlpinion Medical Systems Co., Ltd.ITX2026-05-29
00198953121382VolusonGE Ultrasound Korea Ltd.ITX2026-05-28
08056304455826MyLabC25ESAOTE SPAITX2025-12-10
08056304455833MyLabC30ESAOTE SPAITX2025-12-10
08056304455017MyLabA50ESAOTE SPAITX2025-07-07
08056304455215MyLabE85ESAOTE SPAITX2025-07-07
08056304455307MyLabA70ESAOTE SPAITX2025-07-07
08056304455437MyLabA50ESAOTE SPAITX2025-07-07
08056304455451MyLabA70ESAOTE SPAITX2025-07-07
08056304455635MyLabE80ESAOTE SPAITX2025-07-07
08056304455642MyLabE85ESAOTE SPAITX2025-07-07
04719890960269Neo MedicalAco Healthcare Co., Ltd.ITX2024-09-09
00850055427075HYDROS TRUS ProbePROCEPT BioRobotics CorporationITX2024-09-06
04068151012477ACUSON Origin ICE Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.ITX2024-08-22
04719890960061Aco SmartcareAco Healthcare Co., Ltd.ITX2024-05-13
08056304455628MyLabE80ESAOTE SPAITX2024-03-29