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Z-DOSE29 v1.0

by Agiliti Health, Inc.

Z-DOSE29 v1.0 is a CT system computer (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by Agiliti Health, Inc., cleared under FDA 510(k) K170273 on 28 Apr 2017 and listed in FDA GUDID since 18 Jun 2020 (UDI-DI 00810040260001), active as of 22 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 22 Oct 2026

Documents

510(k) K170273

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810040260001 UDI-DI Date18 Jun 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170273 Date28 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170273 decided 28 Apr 2017 Active
  • FDA GUDID UDI-DI 00810040260001 listed 18 Jun 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170273
  2. Listed FDA GUDID 00810040260001

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Z-DOSE29
Generic name
CT system computer
Model / reference
v1.0
Primary DI / UDI-DI
00810040260001
510(k) Number
FDA product code
JAK
GMDN term
CT system computer
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution

Related devices

Category: CT system computer

Similar devices

Also classified as CT system computer.

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
Other properties (10, all answered No)