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Kosmos OTS iOS Software Package
FDA UDIEUDAMEDClass II (US FDA UDI)
by EchoNous
Identity
- Trade Name
- Kosmos OTS iOS Software Package FDA UDI
- Generic Name
- Ultrasound imaging system application software FDA UDI
- Device Name
- Kosmos OTS iOS Software Package FDA UDI
- Model / Reference
- P007639 FDA UDI
- Description
- Kosmos OTS iOS Software Package FDA UDI
Identifiers
- Primary DI / UDI-DI
- 09353278000717 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- GMDN Term
- Ultrasound imaging system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Ultrasound imaging system application software
Kosmos OTS iOS Software Package by EchoNous — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound imaging system application software.
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- QVCAD System — Qview Medical, Inc. · Class II
Cleared under the same submission
K193518 also covers:
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
- EchoNous
Sources (2)
- FDA UDI 2a79b19a-0fe1-4a63-b085-838b22c02b07 34 fields · synced Jun 17, 2026
- EUDAMED 1 fields · synced Jun 4, 2026