510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K926575Substantially Equivalent

Mammotest Product, Modification

Fischer Imaging Corp., Denver CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K926575 is the FDA 510(k) clearance record for MAMMOTEST PRODUCT, MODIFICATION, a class II device, cleared for Fischer Imaging Corp. on under FDA product code EHD (Unit, X-Ray, Extraoral With Timer). FDA records list 69 510(k) clearances for Fischer Imaging Corp., from to . As of , FDA records show no recalls naming K926575.

Clearance record

Decision date
Received
(119 days to decision)
Product code
EHD Unit, X-Ray, Extraoral With Timer
Regulation
21 CFR 872.1800
Device class
Class II
Review panel
Dental
Applicant
Fischer Imaging Corp. 12300 N. Grant St., Denver CO
510(k) summary
Statement
Third party review
No

Clearances, product code EHD

Trailing 12 months
6 clearances under product code EHD in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code EHD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20262
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260