Identity
- Trade Name
- Z-DOSE29 FDA UDI
- Generic Name
- CT system computer FDA UDI
- Device Name
- XR-29 Solution v1.0 FDA UDI
- Model / Reference
- v1.0 FDA UDI
- Description
- XR-29 Solution v1.0 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810040260001 FDA UDI
- 510(k) Number
- K170273 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- CT system computer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CT system computer
Z-Dose29 by Agiliti Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CT system computer.
- SafeCT-29 — Medic Vision Imaging Solutions · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Agiliti Health, Inc.
Sources (1)
- FDA UDI 6399d9ec-9192-447e-b40d-03f38d98d6f3 34 fields · synced Jun 1, 2026