Identity
- Trade Name
- StatPACS FDA UDI
- Generic Name
- Diagnostic imaging telemedicine system FDA UDI
- Device Name
- StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis. FDA UDI
- Model / Reference
- 1000 FDA UDI
- Description
- StatPACS is a software based PACS product, intended to be used by radiologists, technologists and clinicians to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPACS software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860257001102 FDA UDI
- 510(k) Number
- K092134 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Diagnostic imaging telemedicine system 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
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Manufacturing Date
Yes
FDA UDI
Category: Diagnostic imaging telemedicine system
StatPACS by Nucleushealth, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Nucleushealth, LLC
Sources (1)
- FDA UDI 24333cda-15e9-4342-8b42-c1ddd10861b6 35 fields · synced May 31, 2026