Identity
- Trade Name
- SONIALVISON G4 FDA UDI
- Generic Name
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
- Model / Reference
- 503-78000-22 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04540217040919 FDA UDI
- FDA Product Code
- JAA FDA UDI
- GMDN Term
- Stationary general-purpose fluoroscopic x-ray system, digital FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1650 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
Yes
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: Stationary general-purpose fluoroscopic x-ray system, digital
Sonialvison G4 by Shimadzu Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary general-purpose fluoroscopic x-ray system, digital.
- CANON INC. — CANON INC. · Class II
- NAUTILUS — TECHNIX SPA · Class II
- CLISIS SYSTEMS — GENERAL MEDICAL MERATE SPA · Class II
- Duet DRF — THALES AVS FRANCE SAS · Class II
- STEPHANIX — Stephanix · Class II
- STEPHANIX — Stephanix · Class II
- AMNOTEC — AMNOTEC International Medical GmbH · Class II
- MULTIPURPOSE REMOTE CONTROL R/F SYSTEM — Canon Medical Systems Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shimadzu Corp.
Sources (1)
- FDA UDI 94e541a3-bc45-45be-a1ca-770c6317aa47 32 fields · synced Jun 1, 2026