510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083316Substantially Equivalent

3D Oct-1000 Mark II Optical Coherence Tomography System

Topcon Healthcare, Inc., Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083316 is the FDA 510(k) clearance record for 3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM, a class II device, cleared for Topcon Medical Systems, Inc. on under FDA product code OBO (Tomography, Optical Coherence). FDA's definition for product code OBO reads: "Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases". FDA records list 11 510(k) clearances for Topcon Healthcare, Inc., from to . As of , FDA records show no recalls naming K083316.

Clearance record

Decision date
Received
(123 days to decision)
Product code
OBO Tomography, Optical Coherence
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Topcon Medical Systems, Inc. 310 Ter. Ave., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OBO

Trailing 12 months
3 clearances under product code OBO 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 OBO, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260