FDA.reportPublic FDA data

Panoramic Opthalmoscope

Primary DI
05057056100920
Brand
Panoramic Opthalmoscope
Company
OPTOS PUBLIC LIMITED COMPANY
Model
200Tx
Catalog number
A10092
Published
2016-11-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
MYCOphthalmoscope,Laser,Scanning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYCOphthalmoscope, Laser, ScanningOphthalmic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102492000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102492000P200MAAFOptos Plc.2010-09-30MYC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05057056100920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05057056100920050570561009205057056100920

GMDN Terms#

Term, Definition table
TermDefinition
Scanning-laser ophthalmic imaging systemAn assembly of mains electricity (AC-powered) ophthalmic instruments and digital image capturing/processing devices that uses a low power laser beam to scan in two dimensions over the retina and detect the reflected (or returned) light to generate and capture digital confocal images of the fundus. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s). It is typically used for, e.g., assessment/control of diabetic retinopathy/maculopathy, age-related macular degeneration (AMD), choroidal neovascularization (CNV), detection of retinal vascular disturbances, and diagnosis of chorioditis.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Handling Environment Temperature-40 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+0441383843351gmcleod@optos.com

Regulatory Flags#

DUNS number
346013337
Device count
1
DM exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05057056003856Optos OCT/SLOOCT0003852016-11-23
05057056010212Panoramic OphthalmoscopeP200A10212016-05-27
05057056100210Panoramic OphthalmoscopeP200CA100212016-05-27
05057056106007Panoramic OphthalmoscopeP200TA106002016-05-27
05057056106397OPTOS ADVANCE IMAGE SERVERA106392016-05-27
05057056106502Panoramic OphthalmoscopeP200DTxA106502016-05-27
05057056106885OPTOS ADVANCE IMAGE SERVERA106882016-05-27
05057056107004OCT OphthalmoscopeP200TEA107002018-04-02
05057056905709OPTOS ADVANCES905702016-05-27
05057056108049Optos Arm RestA10804A108042022-12-08
05057056107509OCT Ophthalmoscope P200TxEA107502019-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053677040123EIDONCENTERVUE SPAMYC2026-04-29
08053677040130MAIACENTERVUE SPAMYC2026-04-29
G744OCUB100OcuMet BeaconOcuSciences, Inc.MYC2025-06-25
04059237000235SPECTRALISHeidelberg Engineering GmbHMYC2025-03-24
04059237000723SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237000792SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001027SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04059237001034SPECTRALISHeidelberg Engineering GmbHMYC2024-10-04
04987669101568Scanning Laser OphthalmoscopeNIDEK CO.,LTD.MYC2023-06-12
04987669200636Image filing software NAVIS-EXNIDEK CO.,LTD.MYC2023-06-12
04059237000884SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000891SPECTRALISHeidelberg Engineering GmbHMYC2022-10-26
04059237000815SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
04059237000839SPECTRALISHeidelberg Engineering GmbHMYC2022-02-02
00849233012066Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
10849233012063Busse Hospital DisposablesROBERT BUSSE & CO., INC.MYC2020-04-08
04059237000464SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
04059237000488SPECTRALISHeidelberg Engineering GmbHMYC2020-01-21
08053677040116DRSplusCENTERVUE SPAMYC2019-12-09
04059237000716SPECTRALISHeidelberg Engineering GmbHMYC2019-10-29
05057056107509OCT Ophthalmoscope OPTOS PUBLIC LIMITED COMPANYMYC2019-10-29
04059237000570SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000594SPECTRALISHeidelberg Engineering GmbHMYC2019-04-23
04059237000211SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000501SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000525SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
04059237000549SPECTRALISHeidelberg Engineering GmbHMYC2019-01-03
08053677040093EIDONCENTERVUE SPAMYC2018-07-23
04059237000341SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11
04059237000358SPECTRALISHeidelberg Engineering GmbHMYC2018-07-11