Identity
- Trade Name
- QLAB Advanced Quantification Software FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Model / Reference
- 989605492681 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838090736 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- 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
No
FDA UDI
Category: Radiological PACS software
QLAB Advanced Quantification Software by Philips Ultrasound LLC — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radiological PACS software.
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- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
Sources (2)
- FDA UDI 08fe5c51-26b6-4373-856b-557439faf0a8 32 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026