Identity
- Trade Name
- MEDRAD® Stellant Imaging System Interface 900 FDA UDI
- Generic Name
- CT contrast medium injection system, line-powered, mobile FDA UDI
- Device Name
- Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484) FDA UDI
- Model / Reference
- ISI 900H FDA UDI
- Description
- Injector-Scanner Interface, ISI-900H Module(MODULE, HITACHI, ISI 900H)(84819484) FDA UDI
Identifiers
- Catalog Number
- ISI 900H FDA UDI
- Primary DI / UDI-DI
- 00616258009766 FDA UDI
- 510(k) Number
- K082905 FDA UDI
- FDA Product Code
- DXT FDA UDI
- GMDN Term
- CT contrast medium injection system, line-powered, mobile 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
Yes
FDA UDI
Category: CT contrast medium injection system, line-powered, mobile
MEDRAD® Stellant Imaging System Interface 900 by Bayer Medical Care Inc. — 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, mobile.
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Cleared under the same submission
K082905 also covers:
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant CT Injection System — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface 900 — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface ISI 700 Module — Bayer Medical Care Inc.
- MEDRAD® Stellant Imaging System Interface ISI 800 Module — Bayer Medical Care Inc.
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
- Bayer Medical Care Inc.
Sources (1)
- FDA UDI 0301aedd-fbc2-41fd-bd20-8783ef7f9fb8 36 fields · synced Jun 9, 2026