Identity
- Trade Name
- EVIS X1 VIDEO SYSTEM CENTER FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Model / Reference
- OLYMPUS CV-1500 FDA UDI
Identifiers
- Catalog Number
- N6011240 FDA UDI
- Primary DI / UDI-DI
- 04953170414596 FDA UDI
- FDA Product Code
- FDF FDA UDIFDS FDA UDINWB FDA UDIFET FDA UDINTN FDA UDIEOQ FDA UDIEOB FDA UDI
- GMDN Term
- Endoscopic video image processing/light source system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
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/light source system
Evis X1 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/light source system.
- D-Camsource® — JOIMAX, INC. · Class I
- C-Camsource® — JOIMAX, INC. · Class I
- Camsource® — JOIMAX, INC. · Class I
- Endo Optiks® — Beaver-Visitec International, Inc. · Class II
- Camsource® — JOIMAX, INC. · Class I
- ILO — ILO electronic GmbH · Class I
- Camsource® — JOIMAX, INC. · Class I
- VS3-IR — VISIONSENSE LTD. · Class II
Cleared under the same submission
K222584 also covers:
- COLONOVIDEOSCOPE — Olympus Medical Systems Corporation
- COLONOVIDEOSCOPE — Olympus Medical Systems Corporation
- Foot holder — Olympus Medical Systems Corporation
- Footswitch Conversion cable — Olympus Medical Systems Corporation
- GASTROINTESTINAL VIDEOSCOPE — Olympus Medical Systems Corporation
- PUMP REMOTE CABLE — Olympus Medical Systems Corporation
- Y/C Cable — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 0323a37d-a227-415b-a589-a2fe443302fa 35 fields · synced May 30, 2026