Cleared Traditional

K243645 - IC-Flow™ Imaging System 2.0 (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243645 · Diagnostic Green GmbH · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2025
Decision
300d
Days
Class 2
Risk

K243645 is an FDA 510(k) clearance for the IC-Flow™ Imaging System 2.0. Classified as System, X-ray, Angiographic (product code IZI), Class II - Special Controls.

Submitted by Diagnostic Green GmbH (Kirchheim B. München, DE). The FDA issued a Cleared decision on September 22, 2025 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1600 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Green GmbH devices

Submission Details

510(k) Number K243645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2024
Decision Date September 22, 2025
Days to Decision 300 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
186d slower than avg
Panel avg: 114d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZI System, X-ray, Angiographic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1600
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 General & Plastic Surgery devices follow this clearance model.

Regulatory Consultant

Jeff Yuen and Associates
Moj Eram

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IZI System, X-ray, Angiographic

All 196
Devices cleared under the same product code (IZI) and FDA review panel - the closest regulatory comparables to K243645.
Affirm 800
K243077 · Digital Surgery Systems, Inc. (D.B.A True Digital Surgery) · Jun 2025
Modus IR
K231986 · Synaptive Medical, Inc. · Mar 2024
EXPLORER AIR® II (8001, 8002, 8003)
K234090 · Surgvision GmbH · Mar 2024
Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option)
K231075 · Carl Zeiss Meditec, Inc. · Jun 2023
SPY Portable Handheld Imaging (SPY-PHI) System
K230727 · Novadaq Technologies Ulc (A Part of Stryker) · Jun 2023
EXPLORER AIR® II
K222240 · Surgvision GmbH · Feb 2023