Identity
- Trade Name
- CA2-9AD FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- USP-C029FSA/WR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806167759179 FDA UDI
- 510(k) Number
- K170493 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI892.1570 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
No
FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
Ca2-9ad by Samsung Medison Co., Ltd — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
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Cleared under the same submission
K170493 also covers:
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 — SAMSUNG MEDISON CO., LTD
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD
- HS60 — SAMSUNG MEDISON CO., LTD
- HS60 — SAMSUNG MEDISON CO., LTD
- HS60 — SAMSUNG MEDISON CO., LTD
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
- Samsung Medison Co., Ltd
Sources (2)
- FDA UDI 4196494d-0877-4e1e-9c99-61a3a97bdde9 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 2, 2026