510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K111508Substantially Equivalent

Trident Specimen Radiography System, Model : Rc Tri-00001

Hologic, Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111508 is the FDA 510(k) clearance record for TRIDENT SPECIMEN RADIOGRAPHY SYSTEM, MODEL : RC TRI-00001, a class II device, cleared for Hologic, Inc. on under FDA product code MWP (Cabinet, X-Ray System). FDA records list 189 510(k) clearances for Hologic, Inc., from to . As of , FDA records show no recalls naming K111508.

Clearance record

Decision date
Received
(79 days to decision)
Product code
MWP Cabinet, X-Ray System
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Hologic, Inc. 35 Crosby Dr., Bedford MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWP

Trailing 12 months

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

FDA records show no clearances under product code MWP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MWP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260