Cleared Traditional

K822091 - SIEMENS SIRECUST SYSTEM (FDA 510(k) Clearance)

K822091 · Analogic Corp. · Cardiovascular device
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Oct 1982
Decision
95d
Days
-
Risk

K822091 is an FDA 510(k) clearance for the SIEMENS SIRECUST SYSTEM.

Submitted by Analogic Corp. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1982 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Analogic Corp. devices

Submission Details

510(k) Number K822091 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1982
Decision Date October 18, 1982
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -