FDA.reportPublic FDA data

Olympus

Primary DI
00821925046276
Brand
Olympus
Company
Gyrus ACMI, LLC
Model
ISM-1200364
Device description
Medical Video Recorder Digital Hub, nCare 4K
Published
2025-04-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FTALight, Surgical, Accessories
LMBDevice, Digital Image Storage, Radiological
LMDSystem, Digital Image Communications, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTALight, Surgical, AccessoriesGeneral, Plastic Surgery2
LMBDevice, Digital Image Storage, RadiologicalRadiology1
LMDSystem, Digital Image Communications, RadiologicalRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00821925046276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00821925046276008219250462768219250462760821925046276

GMDN Terms#

Term, Definition table
TermDefinition
Operating room equipment remote controlA hand-operated electronic unit with a configuration of analogue or digital push-buttons (alphanumeric, colour-, or symbol-coded) designed to control the functions of an operating table (e.g., orthopaedic operating table, ophthalmic operating table), lights, and/or cameras in the operating room (OR) from a distance via a connected cable or wirelessly [e.g., radio-frequency (RF), infrared (IR) transmission]. It is intended to be operated by the healthcare provider.

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
00821925019157VOCOM1430002015-10-24
00821925019164GYRUS ACMI, INC1430012015-10-24
00821925019171GYRUS ACMI, INC1430022015-10-24
00821925019225GYRUS ACMI, INC1430062015-10-24
00821925019232GYRUS ACMI, INC1430072015-10-24
00821925019249GYRUS ACMI, INC1430082015-10-24
00821925019300GYRUS ACMI, INC1430032015-10-24
00821925019317GYRUS ACMI, INC1430042015-10-24
00821925019324GYRUS ACMI, INC1430052015-10-24
00821925012738EVONOS GMBH & Co. Kg1300152018-09-04
00821925012783EVONOS1300202018-09-06
00821925012790EVONOS130021-ENT2018-09-06
00821925012806EVONOS1300222018-09-06
00821925012813EVONOS1300232018-09-06
00821925012820EVONOS1300242018-09-06
00821925012837Gyrus ACMI130025-ENT2018-09-06
00821925012929EVONOS1300382018-09-06
00821925013001EVONOS1302012018-09-10
00821925013018EVONOS1302022018-09-10
00821925013025EVONOS1302032018-09-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05415334059139BarcoBarco NVLMD2026-09-21
05415334059924BarcoBarco NVLMD2026-09-21
05415334059931BarcoBarco NVLMD2026-09-21
00850631008902Roentgen WorksBrit Systems, LLCLMB2026-08-27
00850631008896Roentgen WorksBrit Systems, LLCLMB2026-08-14
00850631008889Roentgen WorksBrit Systems, LLCLMB2026-08-13
00850054590183interWORKSAvreo IncLMD2026-08-03
00850054590176interWORKSAvreo IncLMD2026-07-29
00850054590169interWORKSAvreo IncLMD2026-07-08
00850631008872Roentgen WorksBrit Systems, LLCLMB2026-06-23
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-06-05
00850631008865Roentgen WorksBrit Systems, LLCLMB2026-06-05
04995047074816CuratOREIZO CORPORATIONLMB2026-05-29
00850631008858Roentgen WorksBrit Systems, LLCLMB2026-05-26
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-05-12
00628105001212Vitrea ReadCanon Medical Informatics A/SLMD2026-04-27
00745426000028MiPACS Storage ServerApryse Software Corp.LMB2026-04-27
00850631008834Roentgen WorksBrit Systems, LLCLMB2026-04-07
00850631008841Roentgen WorksBrit Systems, LLCLMB2026-04-07
00628105001229Vitrea ReadCanon Medical Informatics A/SLMD2026-04-03
00850631008827Roentgen WorksBrit Systems, LLCLMB2026-03-05
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.LMD2026-01-21
00850631008810Roentgen WorksBrit Systems, LLCLMB2026-01-01
00850631008803Roentgen WorksBrit Systems, LLCLMB2025-12-11
00850054590152interWORKSAvreo IncLMD2025-12-08
00628105001205Vitrea ReadCanon Medical Informatics A/SLMD2025-11-21
00850013331086SentiARSentiar, Inc.LMD2025-11-21
00850013331093SentiARSentiar, Inc.LMD2025-11-21