EyeSuite Imaging

FDA 510(k) K142423 · Haag-Streit AG

Substantially Equivalent

510(k) numberK142423

Submission

Device name
EyeSuite Imaging
Applicant
Haag-Streit AG
Koeniz, Bern, CH
Received
August 28, 2014
Decision date
September 10, 2014
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
NFJ – System, Image Management, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was EyeSuite Imaging cleared by the FDA?

EyeSuite Imaging (K142423) received a 510(k) decision of Substantially Equivalent on September 10, 2014, 13 days after the submission was received.

What is the product code of K142423?

The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.