510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K991012Substantially Equivalent

Siemens Infinity EEG Pod

Siemens Medical Solutions USA, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991012 is the FDA 510(k) clearance record for SIEMENS INFINITY EEG POD, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code OLT (Non-Normalizing Quantitative Electroencephalograph Software). FDA's definition for product code OLT reads: "Analyze electroencephalograph data using conventional methodology to output and display standard electroencephalograph parameters for interpretation by a qualified user". FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K991012.

Clearance record

Decision date
Received
(90 days to decision)
Product code
OLT Non-Normalizing Quantitative Electroencephalograph Software
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Siemens Medical Solutions USA, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary
Third party review
No

Clearances, product code OLT

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