510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K874207Substantially Equivalent

The Purple Iris(tm) Cytopathology Workstation

Intl. Remote Imaging Systems, Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874207 is the FDA 510(k) clearance record for THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION, a class I device, cleared for Intl. Remote Imaging Systems on under FDA product code IBJ (Light, Microscope). FDA records list 14 510(k) clearances for Intl. Remote Imaging Systems, from to . As of , FDA records show no recalls naming K874207.

Clearance record

Decision date
Received
(82 days to decision)
Product code
IBJ Light, Microscope
Regulation
21 CFR 864.3600
Device class
Class I
Review panel
Pathology
Applicant
Intl. Remote Imaging Systems 9162 Eton Ave., Chatsworth CA
Third party review
No

Clearances, product code IBJ

Trailing 12 months

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

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