FDA.reportPublic FDA data

nCare

Primary DI
00810008180952
Brand
nCare
Company
Gyrus ACMI, LLC
Model
1006537
Device description
nCare, SNGL,DRCT SDI,DICOM
Published
2022-12-19
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
LMBDevice, Digital Image Storage, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LMBDevice, Digital Image Storage, RadiologicalRadiology1
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810008180952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810008180952008100081809528100081809520810008180952

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic video image processing unitAn electrically-powered device designed to receive and process the electronic signals sent from a video endoscope or endoscopic video camera; it does not include the endoscope nor light source and is not designed to control the endoscope. It may have additional features which compensate for/enhance the colour and light qualities provided. The resulting picture images are sent to and shown on a visual display unit (VDU), typically to assist the endoscope operator with an ongoing intervention and often to allow the patient visualization of the process; the images can be recorded on a video recorder or stored on computerized media.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
007198742
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00821925035874OLYMPUS30002016-09-30
00821925035911Gyrus ACMI34002016-10-12
00821925041547Gyrus ACMI30252016-09-30
00821925010567Gyrus ACMI39992024-07-24
00821925002746Gyrus ACMIENDO-ST2016-10-14
00821925011410DIEGO703390012016-10-12
00821925011441DIEGO703380002017-05-11
00821925021594SMART701421682015-10-24
00821925021617VOCOM701430192015-10-24
00821925026179Diego703380122016-10-06
00821925028746Diego703390002016-10-06
00821925034174Gyrus ACMI701410322015-10-24
00821925035898OLYMPUS30062016-09-30
00821925041554OLYMPUS30452016-09-30
00821925034013Expandacell708907302018-09-13
00821925034020Gyrus ACMI708909072018-09-13
00821925034037Gyrus ACMI708909082018-09-13
00821925034532Gyrus ACMI8909112018-09-13
00821925037069Rhino Rocket708907292018-09-13
00821925037076Rhino Rocket708907312018-09-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04056481147099Buzz O.R. ComputeBrainlab SELMD2026-07-09
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00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLMB2026-06-05
30009336010630Nissha Medical TechnologiesGRAPHIC CONTROLS ACQUISITION CORPLMD2026-06-01
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00850025268424Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-05-12
08800026700890Medit AuraVueMedit Corp.LMD2026-05-11
00810111225663X-ray AppTreace Medical Concepts, Inc.LMD2026-05-01
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
05415334057258Eonis 32”Barco NVLMD2026-04-13
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
EPIS960010EpisurfViewEpisurf Operations ABLMD2026-03-17
07290018052402aiOSAIDOC MEDICAL LTDLMD2026-03-08
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
00850025268400Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-02-27
04260483290312MammoScapeMeVis Medical Solutions AGLMD2026-02-16
00884838074798IntelliSpace PACS AnywherePhilips Medical Systems Nederland B.V.LMD2026-02-07
00850025268394Vitrea Advanced Visualization Canon Medical Informatics, Inc.LMD2026-01-21
05060634690072EchoGoULTROMICS LIMITEDLMD2026-01-14
04907034602476UR-4MDTEAC MANUFACTURING SOLUTIONS CORPORATIONLMB2026-01-09
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850054590152interWORKSAvreo IncLMD2025-12-08
05415334053045Eonis 3DBarco NVLMD2025-12-01