FDA.reportPublic FDA data

PROBE DRIVING UNIT

Primary DI
04953170311192
Brand
PROBE DRIVING UNIT
Company
OLYMPUS MEDICAL SYSTEMS CORP.
Model
MAJ-1720
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FETEndoscopic video imaging system/component, gastroenterology-urology
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FETEndoscopic Video Imaging System/Component, Gastroenterology-UrologyGastroenterology, Urology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011886000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011886000OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160,Olympus America, Inc.2001-08-27ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04953170311192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04953170311192049531703111924953170311192

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose ultrasound imaging systemA stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)401-1086xx@xx.xx

Regulatory Flags#

DUNS number
711789789
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04953170468308Single Use BML Handle VMAJ-2502N61545312026-10-19
04953170428142VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IRN54270452021-03-03
04953170386138VISERA ELITE II XENON LIGHT SOURCEOLYMPUS CLV-S200-IR2021-02-07
04953170379611HD 3CMOS CAMERA HEADOLYMPUS CH-S200-XZ-EB2019-09-12
04953170386022VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS OTV-S2002019-09-12
04953170393204HD 3CMOS AUTOCLAVABLE CAMERA HEADOLYMPUS CH-S200-XZ-EA2019-09-12
04953170474958THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54233412026-10-05
04953170474965THUNDERBEAT 5 mm,45 cm, Front-actuated Grip Type STB-0545FCSN54234412026-10-05
04953170474972THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54236412026-10-05
04953170474989THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type STB-0535FCSN54237412026-10-05
04953170474996THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54239412026-10-05
04953170475009THUNDERBEAT 5 mm,20 cm,Front-actuated Grip Type STB-0520FCSN54240412026-10-05
04953170025693P CORDMAJ-348125002016-09-21
04953170048548A CORDMH-9692016-09-21
04953170062872A CORDMAJ-8602016-09-21
04953170373763ENDOCAPSULE SOFTWARE 10MAJ-2188N54003402016-09-21
04953170373800ENDOCAPSULE SOFTWARE 10 LIGHTMAJ-2189N54004402016-09-21
04953170373848ENDOCAPSULE SOFTWARE 10 UPGRADE PACKAGEMAJ-2190N54005402016-09-21
04953170360817ENDOCAPSULE SOFTWARE 10 SOFT SERVER-CLIENTMAJ-2038N53688402023-06-21
04953170360824ENDOCAPSULE SOFTWARE 10 SOFTWARE CLIENTMAJ-2039N53689402023-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04580826920721PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920769PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826920806PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826921438PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826926396PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926501PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926518PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926532PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926556PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926600PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826926723PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927010PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826927713PENTAX MedicalPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826927881PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928291PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928307PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928444PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928468PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928567PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928574PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928628PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928703PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826928956PENTAX MedicalPENTAX MEDICAL CORPORATIONODG2026-08-25
04580826930935INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
04580826930959INSPIRAPENTAX MEDICAL CORPORATIONFET2026-08-25
17290016992158SOLO SCOPE Disposable ColonoscopeG.I. VIEW LTDFET2026-08-25
17290016992172SOLO SCOPE Video ControllerG.I. VIEW LTDFET2026-08-25
04953170421594HD CAMERA HEADOLYMPUS MEDICAL SYSTEMS CORP.FET2026-07-22
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONODG2026-06-25
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.ODG2026-06-01