510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K042742Substantially Equivalent

Heidelberg Retina Tomograph II / Rostock Cornea Module (Hrt II / Rcm)

Heidelberg Engineering GmbH, Dossenheim, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042742 is the FDA 510(k) clearance record for HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM), a class II device, cleared for Heidelberg Engineering on under FDA product code MXK (Device, Analysis, Anterior Segment). FDA records list 26 510(k) clearances for Heidelberg Engineering, from to . As of , FDA records show no recalls naming K042742.

Clearance record

Decision date
Received
(9 days to decision)
Product code
MXK Device, Analysis, Anterior Segment
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Heidelberg Engineering Gerhart-Hauptmann-Strasse 30, Dossenheim, DE
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code MXK

Trailing 12 months
2 clearances under product code MXK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MXK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260