Identity
- Trade Name
- Dornier MedTech FDA UDI
- Generic Name
- Basic diagnostic x-ray system operation software FDA UDI
- Device Name
- UIMS Viewing Station SC High Line FDA UDI
- Model / Reference
- UIMS FDA UDI
- Description
- UIMS Viewing Station SC High Line FDA UDI
Identifiers
- Catalog Number
- K1029226 FDA UDI
- Primary DI / UDI-DI
- 04049957000578 FDA UDI
- PMA Number
- P840008 FDA UDI
- FDA Product Code
- NSX FDA UDI
- GMDN Term
- Basic diagnostic x-ray system operation software FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Basic diagnostic x-ray system operation software
Dornier MedTech by Dornier MedTech GmbH — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Basic diagnostic x-ray system operation software.
Cleared under the same submission
P840008 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Dornier MedTech GmbH
Sources (1)
- FDA UDI 4aa911c7-5ae4-4d0b-9bb1-1765451c33c7 35 fields · synced May 31, 2026