510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K002105Substantially Equivalent

Siemens Infinity Sc 6002Xl Enhanced with St Segment Analysis

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

K002105 is the FDA 510(k) clearance record for SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS, a class II device, cleared for Siemens Medical Solutions USA, Inc. on under FDA product code MLD (Monitor, St Segment With Alarm). FDA records list 829 510(k) clearances for Siemens Medical Solutions USA, Inc., from to . As of , FDA records show no recalls naming K002105.

Clearance record

Decision date
Received
(146 days to decision)
Product code
MLD Monitor, St Segment With Alarm
Regulation
21 CFR 870.1025
Device class
Class II
Review panel
Cardiovascular
Applicant
Siemens Medical Solutions USA, Inc. 16 Electronics Ave., Danvers MA
510(k) summary
Summary
Third party review
No

Clearances, product code MLD

Trailing 12 months

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

FDA records show no clearances under product code MLD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MLD, 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