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Targetscan Biopsy Kit

by Envisioneering, LLC 510(k)

Active United States

510(k) K041638

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESK Substantially Equivalent — Kit · Traditional NumberK041638 Date2 Sep 2004ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESK Substantially Equivalent — Kit

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