FDA.reportPublic FDA data

HyperView

Primary DI
00860016689404
Brand
HyperView
Company
Hypermed Technologies Corp
Model
101-A000
Device description
HyperView Camera
Published
2026-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00869661000206PreviousGS10
00860016689404PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00869661000206008696610002068696610002060869661000206
00860016689404008600166894048600166894040860016689404

Regulatory Flags#

DUNS number
138820847
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
50690103211332ForeSightEdwards Lifesciences LLCMUD2024-08-26