510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K925670Substantially Equivalent

Ims-200

Intelligent Medica Imaging, Inc., Palm Beach Gardens FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925670 is the FDA 510(k) clearance record for IMS-200, a class II device, cleared for Intelligent Medica Imaging, Inc. on under FDA product code JOY (Device, Automated Cell-Locating). FDA records list one 510(k) clearance for Intelligent Medica Imaging, Inc. As of , FDA records show no recalls naming K925670.

Clearance record

Decision date
Received
(255 days to decision)
Product code
JOY Device, Automated Cell-Locating
Regulation
21 CFR 864.5260
Device class
Class II
Review panel
Hematology
Applicant
Intelligent Medica Imaging, Inc. 4360 Northlake Blvd.,, Palm Beach Gardens FL
510(k) summary
Statement
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