Identity
- Trade Name
- Sunquest PowerPath FDA UDI
- Generic Name
- Pathology information system application software FDA UDI
- Device Name
- The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. FDA UDI
- Model / Reference
- 13.0 FDA UDI
- Description
- The intended use of Sunquest PowerPath is to support anatomic pathology laboratories in the management of laboratory workflow (order entry through reporting), provide business analytics, and to transfer, store, and display test results and information. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B236PWP13000 FDA UDI
- FDA Product Code
- NVV FDA UDI
- GMDN Term
- Pathology information system application software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2100 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Pathology information system application software
Sunquest PowerPath by CliniSys, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Pathology information system application software.
- Dynamyx Digital Pathology Software — Omnyx, LLC · Class II
- TDHisto/Cyto — TECHNIDATA · Class I
- Sunquest VUE — CliniSys, Inc · Class I
- Sunquest CoPathPlus — CliniSys, Inc · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CliniSys, Inc
Sources (1)
- FDA UDI df4a6593-316d-4c5d-85fc-508c8b718c1b 33 fields · synced May 31, 2026