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QLAB Advanced Quantification Software
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 989606720441
Identity
- Trade Name
- QLAB Advanced Quantification Software EUDAMEDFDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- QLAB Advanced Quantification Software EUDAMEDSoftware Revision 15.5 FDA UDI
- Model / Reference
- 989606720441 EUDAMEDFDA UDI
- Description
- Software Revision 15.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838103603 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM434SX EUDAMED
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z110603 PICTURE ARCHIVING AND COMMUNICATION SYSTEMS EUDAMED
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
QLAB Advanced Quantification Software by Philips Ultrasound LLC — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K040227 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K181264 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 0884838BM434SX | Class IIa | Active |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED 51ae4fe8-9ffd-4c25-8c07-92f8f71ffe95 61 fields · synced Oct 6, 2026
- FDA UDI 334b6967-4926-44e0-a432-31657ecc001a 33 fields · synced May 30, 2026
- FDA 510(k) K040227 1 fields · synced May 18, 2026