Skip to content

Onis-Pacs

by Digitalcore Co., Ltd. 510(k)

Active United States

510(k) K181318

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181318 Date13 Aug 2018ClearedStatusActive

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  • Withdrawn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
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent