DIR 800
510(k) K202391
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202391 | Date21 Jan 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- IZI
- Device class
- Class II
- Regulation
- 21 CFR Part 892.1600
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The DIR 800 is a System, X-Ray, Angiographic device designed for intra-operative fluorescence imaging. It enables visualization of blood vessels using Indocyanine Green (ICG) dye by illuminating the surgical site with near-infrared excitation light and capturing the resulting fluorescence signal via a CMOS sensor. This technology supports enhanced surgical precision in procedures requiring vascular assessment.
The DIR 800 is supplied as a reusable accessory for the Aesculap Aeos surgical microscope and is classified under FDA product code IZI. It is intended for use in radiology settings and has received FDA 510(k) clearance under the Traditional review pathway, classified as a Class II device under regulation 892.1600. No specific sterility or MRI safety information is provided in the data.
Other devices from Aesculap, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the DIR 800 used for in surgical procedures?
The DIR 800 is designed for intra-operative fluorescence imaging, specifically to visualize blood vessels during surgery. It achieves this by illuminating the surgical site with near-infrared excitation light and capturing the resulting fluorescence signal from Indocyanine Green (ICG) dye. This technology supports enhanced surgical precision, particularly in procedures requiring detailed vascular assessment, such as microsurgery or flap monitoring.
How is the DIR 800 supplied and what is its compatibility?
The DIR 800 is supplied as a reusable accessory and is intended for use exclusively with the Aesculap Aeos surgical microscope. Its design ensures seamless integration with this system, enabling fluorescence imaging capabilities during surgical procedures.
Is the DIR 800 single-use or reusable?
The DIR 800 is explicitly designed as a reusable accessory. While the data does not specify sterility requirements or MRI safety, its classification as a reusable device implies it must be properly cleaned, disinfected, and maintained between uses to ensure safety and functionality.
What regulatory pathway and classification apply to the DIR 800?
The DIR 800 has received FDA 510(k) clearance under the Traditional review pathway and is classified as a Class II device under regulation 892.1600. It falls under the product code IZI, indicating its use in radiology settings for angiographic imaging purposes.
Are there any specific storage instructions for the DIR 800?
The provided data does not include explicit storage instructions for the DIR 800. However, as a reusable medical device, it should be stored in a clean, dry environment, protected from physical damage, and according to the manufacturer’s guidelines to maintain its functionality and ensure longevity. Always follow the manufacturer’s instructions for proper handling and storage.