Identity
- Trade Name
- UCES-4 Upgrade Pack 2 FDA UDI
- Generic Name
- Operating room audiovisual data/device management system application software FDA UDI
- Model / Reference
- MAJ-2370 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170406461 FDA UDI
- 510(k) Number
- K172618 FDA UDI
- FDA Product Code
- ODA FDA UDIGCJ FDA UDI
- GMDN Term
- Operating room audiovisual data/device management system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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: Operating room audiovisual data/device management system application software
UCES-4 Upgrade Pack 2 by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- VISIUSmatrix — IMRIS Imaging, Inc. · Class I
- KARL STORZ AIDA — Karl Storz GmbH & Co. KG · Class II
- Connected OR OS — Stryker Corp. · Class II
- INTELLIO LINK Dyonics Power II — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K172618 also covers:
- INTERFACE FOR ESU (FORCE SERIES) — Olympus Medical Systems Corporation
- INTERFACE FOR ESU (VIO SERIES) — Olympus Medical Systems Corporation
- INTERFACE FOR OLYMPUS LINK DEVICE — Olympus Medical Systems Corporation
- MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 — Olympus Medical Systems Corporation
- UNIVERSAL INTERFACE — Olympus Medical Systems Corporation
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
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI f078e803-a108-445f-b34c-93907ba9f8ed 34 fields · synced May 30, 2026