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DeepCT

by Deep01 Limited 510(k)

Active United States

510(k) K182875

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK182875 Date10 Jul 2019ClearedStatusActive

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  • Withdrawn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
QAS
Device Class
Class II
Regulation
21 CFR Part 892.2080
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent