Identity
- Trade Name
- Halo Medical Technologies FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Device Name
- Curved Array Probe FDA UDI
- Model / Reference
- HMT-SURM FDA UDI
- Description
- Curved Array Probe FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860008657381 FDA UDI
- 510(k) Number
- K140899 FDA UDI
- FDA Product Code
- IYO FDA UDI
- GMDN Term
- General-purpose ultrasound imaging 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
Yes
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: General-purpose ultrasound imaging system
Halo Medical Technologies by Halo Medical Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General-purpose ultrasound imaging system.
- SE12-3 Gen II® — SUPERSONIC IMAGINE · Class II
- SUPERSONIC MACH 40 — SUPERSONIC IMAGINE · Class II
- HS50 — SAMSUNG MEDISON CO., LTD · Class II
- EBit Series Diagnostic Ultrasound System — CHISON Medical Technologies Co., Ltd. · Class II
- Display Module(M5, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- WS80A Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
Cleared under the same submission
K140899 also covers:
- Halo Med. Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
- Halo Medical Technologies — HALO MEDICAL TECHNOLOGIES
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
- Halo Medical Technologies
Sources (1)
- FDA UDI de88c90c-eaf3-4768-b7d3-744ab373f0e9 34 fields · synced Jun 8, 2026