Identity
- Trade Name
- OPTIS™ FDA UDI
- Generic Name
- Coronary optical coherence tomography system FDA UDI
- Device Name
- Mobile Next FDA UDI
- Model / Reference
- 1014937 FDA UDI
- Description
- Mobile Next FDA UDI
Identifiers
- Catalog Number
- 1014937 FDA UDI
- Primary DI / UDI-DI
- 05415067036629 FDA UDI
- 510(k) Number
- K210458 FDA UDI
- FDA Product Code
- NQQ FDA UDI
- GMDN Term
- Coronary optical coherence tomography system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Category: Coronary optical coherence tomography system
Optis™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coronary optical coherence tomography system.
- OPTIS™ — LIGHTLAB IMAGING, INC. · Class II
- Luminscan(TM) Disposable Imaging Kit — Micro-Tech (Nanjing) Co., Ltd. · Class II
- ILUMIEN™ — LIGHTLAB IMAGING, INC. · Class II
- ILUMIEN™ OPTIS™ to OPTIS™ — LIGHTLAB IMAGING, INC. · Class II
- OPTIS™ — LIGHTLAB IMAGING, INC. · Class II
- Luminscan(TM) Disposable Imaging Kit — Micro-Tech (Nanjing) Co., Ltd. · Class II
- OPTIS™ — LIGHTLAB IMAGING, INC. · Class II
- Luminscan(TM) Disposable Imaging Kit — Micro-Tech (Nanjing) Co., Ltd. · Class II
Cleared under the same submission
K210458 also covers:
- ILUMIEN™ OPTIS™ to OPTIS™ — LIGHTLAB IMAGING, INC.
- Ultreon™ — LIGHTLAB IMAGING, INC.
- OPTISi™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, INC.
- OPTIS™ — ST. JUDE MEDICAL, 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
- St. Jude Medical, Inc.
Sources (1)
- FDA UDI 72ae2781-d3f9-40bf-b134-1a70815c4340 36 fields · synced May 30, 2026