FDA.reportPublic FDA data

OtoSight Middle Ear Scope

Primary DI
00850013784004
Brand
OtoSight Middle Ear Scope
Company
Photonicare, Inc.
Model
34R
Device description
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults. It is available with and without a battery.
Published
2022-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJGDevice System, Imaging, Tympanic Membrane And Middle Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJGDevice System, Imaging, Tympanic Membrane And Middle EarRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191804000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191804000TOMi ScopePhotonicare, Inc.2019-12-05QJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850013784035PackageGS11In Commercial Distribution
00850013784141PackageGS11In Commercial Distribution
00850013784172PackageGS11In Commercial Distribution
00850013784004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850013784035008500137840358500137840350850013784035
00850013784141008500137841418500137841410850013784141
00850013784172008500137841728500137841720850013784172
00850013784004008500137840048500137840040850013784004

GMDN Terms#

Term, Definition table
TermDefinition
Otoscope, endoscopicAn endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
18664113277support@photoni.care

Regulatory Flags#

DUNS number
078873691
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850013784127OtoSight Middle Ear Scope with Battery34R2023-08-20
00850013784134OtoSight Middle Ear Scope with Battery34R2023-08-20
10850013784070Large OtoSight Speculum Tip QTY 20Large2022-04-15
00850013784110OtoSight Speculum Tip Combination PackageCombo2022-04-15
00850013784097Large OtoSight Speculum Tip QTY 20Large2022-04-15
10850013784087Standard Otosight Speculum Tip QTY 20Standard2022-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850013784127OtoSight Middle Ear Scope with BatteryPhotonicare, Inc.QJG2023-08-20
00850013784134OtoSight Middle Ear Scope with BatteryPhotonicare, Inc.QJG2023-08-20
10850013784070Large OtoSight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15
00850013784110OtoSight Speculum Tip Combination PackagePhotonicare, Inc.QJG2022-04-15
00850013784097Large OtoSight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15
10850013784087Standard Otosight Speculum Tip QTY 20Photonicare, Inc.QJG2022-04-15