LogoFDA 510(k) Search
K Number
K062021
Device Name
KOWA VX-10I
Manufacturer
KOWA CO. LTD.
Date Cleared
2006-11-01

(107 days)

Product Code
HKI
Regulation Number
886.1120
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

KOWA VX -10i is intended for taking pictures of fundus images with mydriatic or without mydriatic.

Device Description

KOWA VX-10i Fundus Camera

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter for the Kowa VX-10i Fundus Camera. It confirms that the device is substantially equivalent to a legally marketed predicate device. This document does not contain information regarding:

  • Acceptance criteria or reported device performance in a table format.
  • Details of a study proving the device meets acceptance criteria.
  • Sample sizes for test sets or training sets.
  • Data provenance.
  • Number or qualifications of experts used for ground truth.
  • Adjudication methods.
  • Multi-reader multi-case (MRMC) comparative effectiveness studies or their effect sizes.
  • Standalone algorithm performance.
  • Type of ground truth used.
  • How ground truth for the training set was established.

The letter's purpose is to grant market clearance based on substantial equivalence, not to present detailed performance study results.

§ 886.1120 Ophthalmic camera.

(a)
Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.(b)
Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.