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Interoperative Linear/Sector Ultrasound Scanner

by Codman & Shurtleff, Inc. 510(k)

Active United States

510(k) K855247

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK855247 Date19 Feb 1987ClearedStatusActive

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  • Withdrawn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
SESE Substantially Equivalent

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