510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011320Substantially Equivalent

Etg-100 Optical Encephalography System

FUJIFILM Healthcare Americas Corporation, Twinsburg OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K011320 is the FDA 510(k) clearance record for ETG-100 OPTICAL ENCEPHALOGRAPHY SYSTEM, a class II device, cleared for Hitachi Medical Systems America, Inc. on under FDA product code DQA (Oximeter). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K011320.

Clearance record

Decision date
Received
(100 days to decision)
Product code
DQA Oximeter
Regulation
21 CFR 870.2700
Device class
Class II
Review panel
Cardiovascular
Applicant
Hitachi Medical Systems America, Inc. 1959 Summit Commerce Park, Twinsburg OH
510(k) summary
Summary
Third party review
No

Clearances, product code DQA

Trailing 12 months
11 clearances under product code DQA in the twelve months to November 2026, December 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQA, trailing twelve months
MonthClearances
December 20253
January 20261
February 20262
March 20260
April 20261
May 20263
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260