510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011877Substantially Equivalent

Ff450 Plus Fundus Camera and Visupac Digital Image Archiving System, or Ff450 Plus Visupac System

Carl Zeiss Jena GmbH, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011877 is the FDA 510(k) clearance record for FF450 PLUS FUNDUS CAMERA AND VISUPAC DIGITAL IMAGE ARCHIVING SYSTEM, OR FF450 PLUS VISUPAC SYSTEM, a class II device, cleared for Carl Zeiss Jena GmbH on under FDA product code HKI (Camera, Ophthalmic, Ac-Powered). FDA records list one 510(k) clearance for Carl Zeiss Jena GmbH. As of , FDA records show no recalls naming K011877.

Clearance record

Decision date
Received
(103 days to decision)
Product code
HKI Camera, Ophthalmic, Ac-Powered
Regulation
21 CFR 886.1120
Device class
Class II
Review panel
Ophthalmic
Applicant
Carl Zeiss Jena GmbH 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

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