Cleared Traditional

K123216 - AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE AN

K123216 is an FDA 510(k) clearance for AIMAGO EASYLDI MICROCIRCULATION CAMERA ..., manufactured by Aimago SA. The device is a Class 2 Cardiovascular device with product code DPT cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K123216 · Aimago SA · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Feb 2013
Decision
115d
Days
Class 2
Risk

K123216 is an FDA 510(k) clearance for the AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY L.... Classified as Probe, Blood-flow, Extravascular (product code DPT), Class II - Special Controls.

Submitted by Aimago SA (Lausanne, CH). The FDA issued a Cleared decision on February 7, 2013 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2120 - the FDA cardiovascular device oversight framework. 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 Aimago SA devices

FDA 510(k) Submission Details - K123216

510(k) Number K123216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date February 07, 2013
Days to Decision 115 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 125d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPT Device Classification - Class 2, Special Controls

Product Code DPT Probe, Blood-flow, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPT Probe, Blood-flow, Extravascular

All 31
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