510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K022164Substantially Equivalent

Zeta Diagnostic Retinal Imaging System

Zeta Development Laboratories, El Dorado Hills CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022164 is the FDA 510(k) clearance record for ZETA DIAGNOSTIC RETINAL IMAGING SYSTEM, a class II device, cleared for Zeta Development Laboratories on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list one 510(k) clearance for Zeta Development Laboratories. As of , FDA records show no recalls naming K022164.

Clearance record

Decision date
Received
(23 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Zeta Development Laboratories 4990 Hillside Cir., El Dorado Hills CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HKI

Trailing 12 months
3 clearances under product code HKI in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKI, trailing twelve months
MonthClearances
November 20250
December 20251
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260