Skip to content

Dlir 1.0

by GE Healthcare Japan Corporation

Dlir 1.0 is a Class II device made by GE Healthcare Japan Corporation, cleared under FDA 510(k) K193170 on 13 Dec 2019 and listed in FDA GUDID since 21 Feb 2020 (UDI-DI 00840682146586), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K193170

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840682146586 UDI-DI Date21 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK193170 Date13 Dec 2019IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K193170 decided 13 Dec 2019 Active
  • FDA GUDID UDI-DI 00840682146586 listed 21 Feb 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K193170
  2. Listed FDA GUDID 00840682146586

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Dlir
Generic name
CT system application software
Model / reference
1.0
Primary DI / UDI-DI
00840682146586
510(k) Number
FDA product code
JAK
GMDN term
CT system application software
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system application software

Other devices from GE Healthcare Japan Corporation

See all devices from GE Healthcare Japan Corporation →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)