FDA.reportPublic FDA data

HyperView

Primary DI
00869661000206
Brand
HyperView
Company
Hypermed Imaging, Inc.
Model
101-A000
Device description
HyperView Camera
Published
2017-11-23
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
MUDOximeter, Tissue Saturation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MUDOximeter, Tissue SaturationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161237000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161237000HyperView Hyperspectral Tissue Oxygenation Measurement SystemHypermed Imaging, Inc.2016-12-16MUD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00869661000206PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869661000206008696610002068696610002060869661000206

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
034813512
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00869661000213HyperView102-A0012017-11-23
00869661000220HyperView103-A0012017-11-23
00869661000237HyperView105-A0042017-11-23
00869661000244HyperView105-A0052017-11-23
00869661000251HyperView105-A0022017-11-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860016689404HyperViewHypermed Technologies CorpMUD2026-11-05
10884521860896INVOSCovidien LPMUD2026-10-31
10884521860902INVOSCovidien LPMUD2026-10-31
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyMUD2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyMUD2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyMUD2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyMUD2026-10-04
00885403523437HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00885403523451HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00885403523475HemoSphere AltaBecton, Dickinson And CompanyMUD2026-08-06
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyMUD2026-04-15
00690103219395Smart Pressure ControllerEdwards Lifesciences LLCMUD2025-09-10
00690103219531Acumen IQ PlusEdwards Lifesciences LLCMUD2025-09-10
00690103219609VitaWaveEdwards Lifesciences LLCMUD2025-09-10
00690103219616ForeSight IQEdwards Lifesciences LLCMUD2025-07-11
00690103217711Acumen AFM™ cable - HemoSphere Alta™ monitorEdwards Lifesciences LLCMUD2025-07-11
00690103217728HemoSphereEdwards Lifesciences LLCMUD2025-07-11
10884521845985INVOSCovidien LPMUD2025-07-03
00690103217957HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217964HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
00690103217971HemoSphere AltaEdwards Lifesciences LLCMUD2025-03-13
10884521845039INVOSCovidien LPMUD2025-02-08
20884521845036INVOSCovidien LPMUD2025-02-08
00690103218879HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103218886HemoSphere VitaEdwards Lifesciences LLCMUD2024-08-28
00690103211313ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211320ForeSightEdwards Lifesciences LLCMUD2024-08-26
00690103211337ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211318ForeSightEdwards Lifesciences LLCMUD2024-08-26
50690103211325ForeSightEdwards Lifesciences LLCMUD2024-08-26