Identity
- Trade Name
- Medistim MiraQ Ultimate System FDA UDI
- Generic Name
- Cardiovascular ultrasound imaging system FDA UDI
- Model / Reference
- MQU14012 FDA UDI
Identifiers
- Catalog Number
- MQU14012 FDA UDI
- Primary DI / UDI-DI
- 07070554103932 FDA UDI
- 510(k) Number
- K102595 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIDPW FDA UDI
- GMDN Term
- Cardiovascular ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 FDA UDI870.2100 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
Yes
FDA UDI
Category: Cardiovascular ultrasound imaging system
Medistim MiraQ Ultimate System by Medi-Stim Asa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiovascular ultrasound imaging system.
- Vivid — GE Medical Systems (China) Co., Ltd. · Class II
- iLab™ — Boston Scientific · Class II
- SLT IVUS P1 Display Unit — Provisio Medical, Inc. · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- iLab Ultrasound Imaging System — Boston Scientific · Class II
- AVVIGO™+ — Boston Scientific · Class II
- AVVIGO™+ — Boston Scientific · Class II
- Vivid — Ge Vingmed Ultrasound · Class II
Cleared under the same submission
K102595 also covers:
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Cardiac System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Ultimate System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
- Medistim MiraQ Vascular System — Medi-Stim Asa
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
- Medi-Stim Asa
Sources (1)
- FDA UDI e6db8a5c-126a-4dff-8d20-5f63bf0775ca 34 fields · synced May 30, 2026