Identity
- Trade Name
- OneView FDA UDI
- Generic Name
- Cardiology information system application software FDA UDI
- Device Name
- ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline the pacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session data into one, convenient platform. With a click of a button, OneView captures all relevant pacemaker/ICD data, including: Device specifications Measurements for every session Settings Episode details Reports Physician sign-off OneView also provides insight into historical patient trends and other critical clinical data over time, helping to prioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as it supports remote interrogation, in-person interrogation and in-person programming. FDA UDI
- Model / Reference
- OneView FDA UDI
- Description
- ScottCare’s OneView is an innovative, cardiology software tool used to simplify and streamline the pacemaker/ICD monitoring session reporting process by consolidating all device manufacturers’ session data into one, convenient platform. With a click of a button, OneView captures all relevant pacemaker/ICD data, including: Device specifications Measurements for every session Settings Episode details Reports Physician sign-off OneView also provides insight into historical patient trends and other critical clinical data over time, helping to prioritize patients with more severe issues. In addition, data can be gathered from almost anywhere, as it supports remote interrogation, in-person interrogation and in-person programming. FDA UDI
Identifiers
- Catalog Number
- 101247 FDA UDI
- Primary DI / UDI-DI
- 00856298006206 FDA UDI
- 510(k) Number
- K061780 FDA UDI
- FDA Product Code
- DXH FDA UDI
- GMDN Term
- Cardiology information system application software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2920 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiology information system application software
OneView by Scottcare Corporation, The — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Cardiology information system application software.
- Welch Allyn, Inc. — Welch Allyn, Inc. · Class II
- CardioConfirm — MORTARA INSTRUMENT, INC. · Class II
- SENTINEL — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Pathfinder SL — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Cordiana Dx16 — Cordiana Medical Informatics AG · Class II
- Epicardia 5000 — MEDICOMP, INC. · Class II
- Lifescreen Pro — SPACELABS HEALTHCARE (WASHINGTON), INC · Class II
- Cardio Server — EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC · Class II
Cleared under the same submission
K061780 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
- Scottcare Corporation, The
Sources (1)
- FDA UDI 0c938f1f-992c-42b1-99f9-ca16b39fb29f 36 fields · synced May 30, 2026