510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K892711Substantially Equivalent

Quantim 2000I Digital Image Analysis System

Quantitative Cardiac Systems (Qcs), Inc., Ann Arbor MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892711 is the FDA 510(k) clearance record for QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM, a class II device, cleared for Quantitative Cardiac Systems (Qcs), Inc. on under FDA product code LLZ (System, Image Processing, Radiological). FDA records list one 510(k) clearance for Quantitative Cardiac Systems (Qcs), Inc. As of , FDA records show no recalls naming K892711.

Clearance record

Decision date
Received
(244 days to decision)
Product code
LLZ System, Image Processing, Radiological
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Quantitative Cardiac Systems (Qcs), Inc. 115 Research Dr., Ann Arbor MI
Third party review
No

Clearances, product code LLZ

Trailing 12 months
48 clearances under product code LLZ in the twelve months to October 2026, July 2026 the highest month at 8.
Show the numbers
Monthly 510(k) clearances under FDA product code LLZ, trailing twelve months
MonthClearances
November 20254
December 20251
January 20263
February 20264
March 20266
April 20262
May 20265
June 20265
July 20268
August 20263
September 20267
October 20260