Zeiss Infrared 800 with Flow 800 Option

Q: What is the product code of K100468?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.

FDA 510(k) K100468 · Carl Zeiss Surgical GmbH

Substantially Equivalent

510(k) numberK100468

Submission

Device name: Zeiss Infrared 800 with Flow 800 Option
Applicant: Carl Zeiss Surgical GmbH
Dublin, CA, US
Received: February 18, 2010
Decision date: March 3, 2010
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: IZI – System, X-Ray, Angiographic
Device class: Class II (moderate risk)
Regulation: 21 CFR 892.1600
Specialty: Radiology

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K222240	Explorer Air® IIIZI · Traditional	Surgvision GmbH	02/28/2023SE
K214097	Explorer Air IIIZI · Traditional	Surgvision GmbH	02/25/2022SE

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Questions and answers

When was Zeiss Infrared 800 with Flow 800 Option cleared by the FDA?

Zeiss Infrared 800 with Flow 800 Option (K100468) received a 510(k) decision of Substantially Equivalent on March 3, 2010, 13 days after the submission was received.

What is the product code of K100468?

The FDA product code is IZI – System, X-Ray, Angiographic, a Class II (moderate risk) device regulated under 21 CFR 892.1600.