Identity
- Trade Name
- IMROC -IR EUDAMEDMOC FDA UDI
- Generic Name
- Patient audiovisual communication/entertainment system FDA UDI
- Device Name
- IMROC -IR EUDAMEDMRI multi-channel optical communication system FDA UDI
- Model / Reference
- 0000 EUDAMEDIMROC-IR with OptoACTIVE FDA UDI
- Description
- MRI multi-channel optical communication system FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290019141006 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290019141006WR EUDAMED
- Direct Marketing DI
- 07290019141006 EUDAMED
- 510(k) Number
- K121239 FDA UDI
- FDA Product Code
- LNH FDA UDI
- EMDN Code
- Z1105018099 MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Patient audiovisual communication/entertainment system FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1000 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: Patient audiovisual communication/entertainment system
Moc by Optoacoustics, Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Patient audiovisual communication/entertainment system.
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- Silent Scan — Avotec, Inc. · Class II
- MRIview — Mriaudio · Class II
- MRIaudio1506 — Mriaudio · Class II
- MRIaudioPREM1000 with MRIview — Mriaudio · Class II
- MRIaudioPREM1000 — Mriaudio · Class II
- Innovision — Innovere Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Optoacoustics, Ltd.
Sources (2)
- FDA UDI 59857ee2-1efe-4899-ad61-81caeaa5e6b6 36 fields · synced Jun 18, 2026
- EUDAMED 6074d7ac-d412-4a55-8ea8-e571b7a3e7c1 61 fields · synced Jun 18, 2026