510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984188Substantially Equivalent

Automated Cellular Imaging System (Acis)

Chroma Vision Medical Systems, Inc., Flower Mound TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984188 is the FDA 510(k) clearance record for AUTOMATED CELLULAR IMAGING SYSTEM (ACIS), a class II device, cleared for Chroma Vision Medical Systems, Inc. on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list 3 510(k) clearances for Chroma Vision Medical Systems, Inc., from to . As of , FDA records show no recalls naming K984188.

Clearance record

Decision date
Received
(247 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Chroma Vision Medical Systems, Inc. 3535 Firewheel Dr., Flower Mound TX
510(k) summary
Summary
Third party review
No

Clearances, product code JOY

Trailing 12 months

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

FDA records show no clearances under product code JOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JOY, 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