EyeSuite Imaging— 510(k) K142423

Substantially Equivalent

Haag-Streit AG

FDA 510(k) clearance K142423 for EyeSuite Imaging, Substantially Equivalent on 2014-09-10. Applicant: Haag-Streit AG. Device class: 2.

Clearance details

Applicant: Haag-Streit AG
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2014-08-28
Decision date: 2014-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Koeniz, Bern, CH

Download summary PDF View on FDA.gov ↗

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Recalls naming K142423

K-number listed on FDA's recall record

Z-1500-2017 — EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra Ocular Lenses (IOLs).Class II·Terminated·Haag-Streit USA Inc·20170105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K142423.

Data sourced from openFDA. This site is unofficial and independent of the FDA.