510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012138Substantially Equivalent

Modification to Acis (Automated Cellular Imaging System)

Chroma Vision Medical Systems, Inc., San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012138 is the FDA 510(k) clearance record for MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM), a class II device, cleared for Chroma Vision Medical Systems, Inc. on under FDA product code MYA (Immunohistochemistry Antibody Assay, Estrogen Receptor). FDA records list 3 510(k) clearances for Chroma Vision Medical Systems, Inc., from to . As of , FDA records show no recalls naming K012138.

Clearance record

Decision date
Received
(447 days to decision)
Product code
MYA Immunohistochemistry Antibody Assay, Estrogen Receptor
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Chroma Vision Medical Systems, Inc. 33171 Paseo Cerveza, San Juan Capistrano CA
510(k) summary
Statement
Third party review
No

Clearances, product code MYA

Trailing 12 months

FDA records hold no clearances under product code MYA in the trailing twelve months.

FDA records show no clearances under product code MYA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MYA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260