Identity
- Trade Name
- PreOp FDA UDI
- Generic Name
- Bioelectrical signal analysis software FDA UDI
- Device Name
- PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image. FDA UDI
- Model / Reference
- v2 FDA UDI
- Description
- PreOp is active medical device software (MSDW) intended for use by a trained Epilog EEG technologist / Operator in combination with Persyst EEG Review and Analysis Software on both adult and pediatric subjects at least 3 years of age for 3D visualization of the human brain function recorded with EEG and using a patient-specific MR image. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05430000733021 FDA UDI
- 510(k) Number
- K172858 FDA UDI
- FDA Product Code
- OLX FDA UDI
- GMDN Term
- Bioelectrical signal analysis software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1400 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: Bioelectrical signal analysis software
PreOp by Clouds of Care — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bioelectrical signal analysis software.
- Synchrony Dysphagia Solutions by ACP — ACCELERATED CARE PLUS CORP. · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- OmniME — ACCELERATED CARE PLUS CORP. · Class I
- SmartScreener-Plus2 Screener Launch — Intelligent Hearing Systems Corp. · Class II
- SmartDPOAE Software — Intelligent Hearing Systems Corp. · Class II
- encevis — AIT Austrian Institute of Technology GmbH · Class II
- MyoVision Software — PRECISION BIOMETRICS INC · Class II
- encevis — AIT Austrian Institute of Technology GmbH · Class II
Cleared under the same submission
K172858 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Clouds of Care
Sources (1)
- FDA UDI 67abb55e-ed99-407c-b359-052b5822fe10 34 fields · synced May 31, 2026