Identity
- Trade Name
- LF FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, stationary FDA UDI
- Device Name
- OptiOne Single-Head CT Contrast Delivery System FDA UDI
- Model / Reference
- 847003C FDA UDI
- Description
- OptiOne Single-Head CT Contrast Delivery System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10746190004325 FDA UDI
- 510(k) Number
- K152361 FDA UDI
- FDA Product Code
- IZQ FDA UDI
- GMDN Term
- CT contrast medium injection system, line-powered, stationary FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
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: CT contrast medium injection system, line-powered, stationary
Lf by Liebel-Flarsheim Company, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CT contrast medium injection system, line-powered, stationary.
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- Injector Head — Bracco Injeneering · Class II
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- Remote Control — Bracco Injeneering · Class II
Cleared under the same submission
K152361 also covers:
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
- Liebel-Flarsheim Company, LLC
Sources (1)
- FDA UDI 90f7ebe0-e969-4ea0-8532-a214c22074f7 34 fields · synced Jun 8, 2026