Identity
- Trade Name
- OrthoView FDA UDI
- Generic Name
- Radiological PACS software FDA UDI
- Device Name
- OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions. FDA UDI
- Model / Reference
- 7.1.1 FDA UDI
- Description
- OrthoView provides the means for a surgeon to plan surgery by assessing medical images loaded into it. This enables the surgeon to gather measurements and angles of anatomical landmarks, visualize the effect of the surgery by animating regions of the image, size and position templates representing prosthetic or fixation devices and output reports specifying the measurements and device decisions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- B021711WINWK0 FDA UDI
- 510(k) Number
- K063327 FDA UDI
- FDA Product Code
- LLZ FDA UDI
- GMDN Term
- Radiological PACS software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.2050 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiological PACS software
OrthoView by Meridian Technique, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological PACS software.
- AVIEW — CORELINE SOFT CO., LTD. · Class II
- ThinkingNet — THINKING SYSTEMS CORP. · Class II
- IMAGEGRID RADIOLOGY VIEWER SYSTEM — Candelis, Inc. · Class II
- EAGLESOFT — PATTERSON TECHNOLOGY CENTER · Class II
- QuantX — Qlarity Imaging · Class II
- interWORKS — Avreo, Inc. · Class I
- NovaPACS — Novarad Corporation · Class II
- OrthoNext™ Platform System Software — Orthofix, Inc. · Class II
Cleared under the same submission
K063327 also covers:
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
- OrthoView — Meridian Technique, Ltd.
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
- Meridian Technique, Ltd.
Sources (1)
- FDA UDI eca8e048-e20c-4dbd-98bb-ebb39961a23f 34 fields · synced May 30, 2026