510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123442Substantially Equivalent

Xoft Axxent Cervical Applicators

iCAD, Inc., Nashua NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123442 is the FDA 510(k) clearance record for XOFT AXXENT CERVICAL APPLICATORS, a class II device, cleared for Icad, Inc. on under FDA product code JAQ (System, Applicator, Radionuclide, Remote-Controlled). FDA records list 13 510(k) clearances for Icad, Inc., from to . As of , FDA records show no recalls naming K123442.

Clearance record

Decision date
Received
(111 days to decision)
Product code
JAQ System, Applicator, Radionuclide, Remote-Controlled
Regulation
21 CFR 892.5700
Device class
Class II
Review panel
Radiology
Applicant
Icad, Inc. 98 Spit Brook Rd., Suite 100, Nashua NH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JAQ

Trailing 12 months
4 clearances under product code JAQ in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JAQ, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20260