510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K992467Substantially Equivalent

Imagclear Mammography Review System

dba Systems, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K992467 is the FDA 510(k) clearance record for IMAGCLEAR MAMMOGRAPHY REVIEW SYSTEM, a class II device, cleared for Dba Systems, Inc. on under FDA product code LMA (Digitizer, Image, Radiological). FDA records list 2 510(k) clearances for Dba Systems, Inc., from to . As of , FDA records show no recalls naming K992467.

Clearance record

Decision date
Received
(202 days to decision)
Product code
LMA Digitizer, Image, Radiological
Regulation
21 CFR 892.2030
Device class
Class II
Review panel
Radiology
Applicant
Dba Systems, Inc. 555 13th St., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code LMA

Trailing 12 months

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

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