Nidek Advanced Vision Information System (Navis)

Q: What is the product code of K013694?

The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.

FDA 510(k) K013694 · Nidek, Inc.

Substantially Equivalent

510(k) numberK013694

Submission

Device name: Nidek Advanced Vision Information System (Navis)
Applicant: Nidek, Inc.
Lake Forest, CA, US
Received: November 7, 2001
Decision date: November 19, 2002
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: NFJ – System, Image Management, Ophthalmic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.2050
Specialty: Radiology

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K232088	Altris IMSNFJ · Traditional	Altris, Inc.	07/31/2023SE
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K213527	ForumNFJ · Traditional	Carl Zeiss Meditec, AG	08/15/2022SE

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Questions and answers

When was Nidek Advanced Vision Information System (Navis) cleared by the FDA?

Nidek Advanced Vision Information System (Navis) (K013694) received a 510(k) decision of Substantially Equivalent on November 19, 2002, 377 days after the submission was received.

What is the product code of K013694?

The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.