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Dispensor, Xenon Gas

by Diagnostic Isotapes, Inc. 510(k)

Active United States

510(k) K781933

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781933 Date4 Dec 1978ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IYT
Device Class
Class II
Regulation
21 CFR Part 892.1390
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent