Identity
- Trade Name
- Exo Iris Ultrasound System FDA UDI
- Generic Name
- Hand-held ultrasound imaging system, body-surface FDA UDI
- Device Name
- Exo Iris Ultrasound System is a procedural pack that contains Exo Iris probe, Duo Cable, Wireless charger, wall charger, and ultrasound gel. FDA UDI
- Model / Reference
- EI2001 FDA UDI
- Description
- Exo Iris Ultrasound System is a procedural pack that contains Exo Iris probe, Duo Cable, Wireless charger, wall charger, and ultrasound gel. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850018318068 FDA UDI
- 510(k) Number
- K222198 FDA UDI
- FDA Product Code
- IYN FDA UDIIYO FDA UDIITX FDA UDI
- GMDN Term
- Hand-held ultrasound imaging system, body-surface 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
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Hand-held ultrasound imaging system, body-surface
Exo Iris Ultrasound System by Exo Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held ultrasound imaging system, body-surface.
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- GUI — Sonivate Medical, Inc. · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
- Butterfly iQ3 Charger Kit — Butterfly Network, Inc. · Class II
- Clarius Ultrasound Scanner — Clarius Mobile Health Corp · Class II
Cleared under the same submission
K222198 also covers:
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
- Exo Imaging
Sources (1)
- FDA UDI 924b1bfd-8027-4351-b317-b514c3baa2b8 34 fields · synced May 30, 2026