Identity
- Trade Name
- VISERA ELITE VIDEO SYSTEM CENTER FDA UDI
- Generic Name
- Endoscopic video image processing unit FDA UDI
- Device Name
- "OTV-S190 VISERA ELITE VIDEO SYSTEM CNTR" FDA UDI
- Model / Reference
- OLYMPUS OTV-S190 FDA UDI
- Description
- "OTV-S190 VISERA ELITE VIDEO SYSTEM CNTR" FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170301964 FDA UDI
- 510(k) Number
- K111425 FDA UDI
- FDA Product Code
- NWB FDA UDIFGB FDA UDIHET FDA UDIEOQ FDA UDIEOB FDA UDIGCJ FDA UDI
- GMDN Term
- Endoscopic video image processing unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI884.1720 FDA UDI874.4680 FDA UDI874.4760 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: Endoscopic video image processing unit
Visera Elite Video System Center by Olympus Medical Systems Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video image processing unit.
- Pixa — SANTA BARBARA IMAGING SYSTEMS, INC. · Class II
- ILO — ILO electronic GmbH · Class I
- AURORA® Surgiscope® — Integra Lifesciences Corp. · Class II
- VIDEO PROCESSOR — PENTAX of America, Inc. · Class II
- Digital Video Processor — Hunan Vathin Medical Instrument Co., Ltd · Class II
- ILO — ILO electronic GmbH · Class I
- 3NT Video Console — 3nt Medical , Ltd. · Class II
- HDMI cable — MacroLux Medical Technology Co., Ltd. · Class II
Cleared under the same submission
K111425 also covers:
- COMMUNICATION CABLE FOR SYSTEM CENTER 1.8M — Olympus Medical Systems Corporation
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE — Olympus Medical Systems Corporation
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE — Olympus Medical Systems Corporation
- HDTV MONITOR REMOTE CABLE 2.5M — Olympus Medical Systems Corporation
- LIGHT SOURCE CABLE — Olympus Medical Systems Corporation
- LIGHT SOURCE CABLE WITH REMOTE 1.8M — Olympus Medical Systems Corporation
- MULTI REMOTE CABLE 8.5M — Olympus Medical Systems Corporation
- VISERA ELITE XENON LIGHT SOURCE — 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 d2bd64ac-2211-49d6-8a64-460d5a8281b1 35 fields · synced Jun 1, 2026