FDA.reportPublic FDA data

SonoScape

Primary DI
06945868603854
Brand
SonoScape
Company
SONOSCAPE MEDICAL CORP.
Model
VLS-51T
Device description
VLS-51T Light Source
Published
2022-04-07
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
NWBEndoscope, Accessories, Narrow Band Spectrum

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NWBEndoscope, Accessories, Narrow Band SpectrumGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211882000HD-550 Video Endoscope SystemSonoscape Medical Corp.2022-04-01NWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945868603854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945868603854069458686038546945868603854

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic light source unit, line-poweredA mains electricity (AC-powered) unit designed to produce light of high intensity, often called cold light, for viewing surgical fields and body cavities during endoscopy (e.g., used with an arthroscope, cystoscope, laparoscope, gastroscope); it may have additional non-endoscopic lighting applications. It is designed as a bench-top unit with controls and a source of bright light [e.g., using a xenon (Xe) light bulb] that is channelled to the endoscope via a light cable to illuminate the site of observation/intervention while minimizing tissue heating.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
545342185
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945868603434SonoScapeEG-550L2022-04-07
06945868603441SonoScapeEC-5502022-04-07
06945868603458SonoScapeEC-550T2022-04-07
06945868603465SonoScapeEC-550L2022-04-07
06945868603540SonoScapeHD-550Exp2022-04-07
06945868603557SonoScapeHD-550Pro2022-04-07
06945868603564SonoScapeHD-550S2022-04-07
06945868603571SonoScapeHD-5102022-04-07
06945868603588SonoScapeHD-500Plus2022-04-07
06945868603601SonoScapeVLS-55Q2022-04-07
06945868603618SonoScapeVLS-55T2022-04-07
06945868603861SonoScapeVLS-51D2022-04-07
06945868605155SonoScapeHD-5502022-04-07
06945868605193SonoScapeEC-550L/T2022-04-07
06945868605186SonoScapeEG-5502022-04-07
06945868610135SonoScapeX11 Exp2025-12-17
06945868610142SonoScapeX11 Elite2025-12-17
06945868610159SonoScapeX11 Pro2025-12-17
06945868610166SonoScapeX11 Plus2025-12-17
06945868610173SonoScapeX11 Super2025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04547410513790FUJIFILMFUJIFILM CORPORATIONNWB2025-05-31
04953170423628GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2025-05-26
07613327616682SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616699SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616705SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616712SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616729SPYSTRYKER CORPORATIONNWB2024-02-27
07613327616743SPYSTRYKER CORPORATIONNWB2024-02-27
076133276089151788STRYKER CORPORATIONNWB2023-12-11
04953170414596EVIS X1 VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041560912G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041562312G-SDI cableOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
0495317041563012G-SDI cable 8.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
049531704156473G-SDI cable 1.5MOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170415654Foot holderOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170415685Footswitch Conversion cableOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170420191GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170424281COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2023-07-04
04953170411526RHINO-LARYNGO VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-24
04953170216961EVIS EXERA II XENON LIGHT SOURCEOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170338496VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386015VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170386060VISERA ELITE II VIDEO SYSTEM CENTEROLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-17
04953170026324KEY BOARDOLYMPUS MEDICAL SYSTEMS CORP.NWB2021-12-16
04547410446081FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04547410446104FUJIFILMFUJIFILM CORPORATIONNWB2021-09-29
04953170409820CONNECTING TUBEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-12-15
04953170416132EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-08-27
04953170420702EVIS EXERA III COLONOVIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.NWB2020-08-27
04042761083485OlympusOLYMPUS Winter & Ibe GmbHNWB2020-07-31