IC-Flow Imaging System 2.0
FDA 510(k) K243645 · Diagnostic Green GmbH
510(k) numberK243645
Submission
- Device name
- IC-Flow Imaging System 2.0
- Applicant
- Diagnostic Green GmbH
Kirchheim B. München, DE - Received
- November 26, 2024
- Decision date
- September 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K230727 | SPY Portable Handheld Imaging (SPY-PHI) SystemIZI · Traditional | Novadaq Technologies Ulc (A Part of Stryker) | 06/05/2023SE |
| K222240 | Explorer Air® IIIZI · Traditional | Surgvision GmbH | 02/28/2023SE |
| K214097 | Explorer Air IIIZI · Traditional | Surgvision GmbH | 02/25/2022SE |
| K202391 | Dir 800IZI · Traditional | Aesculap, Inc. | 01/21/2021SE |
Questions and answers
When was IC-Flow Imaging System 2.0 cleared by the FDA?
IC-Flow Imaging System 2.0 (K243645) received a 510(k) decision of Substantially Equivalent on September 22, 2025, 300 days after the submission was received.
What is the product code of K243645?
The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.