510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K111531Substantially Equivalent

Rha2020

Annidis Health Systems Corp., Ottawa, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111531 is the FDA 510(k) clearance record for RHA2020, a class II device, cleared for Annidis Health Systems Corp. on under FDA product code HLI (Ophthalmoscope, Ac-Powered). FDA records list one 510(k) clearance for Annidis Health Systems Corp. As of , FDA records show no recalls naming K111531.

Clearance record

Decision date
Received
(36 days to decision)
Product code
HLI Ophthalmoscope, Ac-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Annidis Health Systems Corp. 2650 Queensview Dr., Ottawa, Ontario, CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HLI

Trailing 12 months

FDA records hold no clearances under product code HLI in the trailing twelve months.

FDA records show no clearances under product code HLI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260