KOWA VX-20

GUDID 04987646807278

The KOWA VX-20 is intended for taking pictures of retinal images with mydriatic or without mydriatic.

KOWA COMPANY,LTD.

Ophthalmic fundus camera

• Primary Device ID: 04987646807278
• NIH Device Record Key: 3a2ff88e-4ba6-47ea-939d-190380f7b680
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOWA VX-20
• Version Model Number: K9L56BK
• Company DUNS: 692281073
• Company Name: KOWA COMPANY,LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Height: 720 Millimeter
• Depth: 540 Millimeter
• Width: 390 Millimeter
• Weight: 39 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -15 Degrees Celsius and 55 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 10 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987646807278 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112330

FDA Product Code

• HKI: Camera, Ophthalmic, Ac-Powered

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

Devices Manufactured by KOWA COMPANY,LTD.

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• 04987646810056 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810063 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646810070 - KOWA SL-19: 2022-12-15 KOWA SL-19 is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsu
• 04987646809128 - KOWA nonmyd AF: 2020-01-23 KOWA nonmyd AF is intended for use with retinal image capturing without requiring the patients to take any mydriatic.
• 04987646807728 - KOWA DR-1α: 2019-06-18 The KOWA DR-1α is an ocular surface interferometer, which is an ophthalmic imaging device that is intended for use by physician