Vitrea Enterprise Viewer
- Primary DI
- 00853866003223
- Brand
- Vitrea Enterprise Viewer
- Company
- Canon Medical Informatics, Inc.
- Model
- 7.0
- Device description
- VitreaView is a cross-browser, cross-platform, zero-footprint universal medical image viewer solution capable of displaying both DICOM and non-DICOM medical images for diagnosis, review, communication, and reporting. VitreaView enables clinicians and other medical professionals to access patients' medical images with integrations into a variety of medical record systems, such as Electronic Health Record (EHR), Electronic Medical Record (EMR), Health Information Exchange (HIE), Personal Health Record (PHR), and image exchange systems. It supports the physician in medical image viewing and treatment planning. VitreaView offers medical professionals a universal viewer for accessing multi-dimensional imaging data in context with reports from enterprise patient health information databases, fosters collaboration, and provides workflows and interfaces appropriate for referring physicians and clinicians. IT departments will not have to incur time to install client systems, due to the zero footprint/zero download nature of VitreaView. VitreaView offers scalability to add new users as demand grows, may be deployed in a virtualized environment, and is designed to be integrated with enterprise patient health information databases. When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
- Published
- 2017-03-15
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes#
| Code | Name |
|---|---|
| LLZ | System, Image Processing, Radiological |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | Radiology | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K150738 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00853866003223 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00853866003223 | 00853866003223 | 853866003223 | 0853866003223 |
GMDN Terms#
| Term | Definition |
|---|---|
| Radiological PACS-dedicated management software | A software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models. |
Regulatory Flags#
- DUNS number
- 160061651
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00850025268431 | Vitrea Advanced Visualization | 7.16.5 | 2026-09-21 | |
| 00850025268417 | Vitrea Advanced Visualization | 7.16.4.SU02 | 2026-06-05 | |
| 00850025268257 | Vitrea Advanced Visualization | 7.16.1 | 2024-09-05 | |
| 00850025268387 | Vitrea Advanced Visualization | 7.16.3.SU02 | 2025-11-03 | |
| 00850025268424 | Vitrea Advanced Visualization | 7.16.3.SU03 | 2026-05-12 | |
| 00850025268400 | Vitrea Advanced Visualization | 7.16.4.SU01 | 2026-02-27 | |
| 00850025268394 | Vitrea Advanced Visualization | 7.16.4 | 2026-01-21 | |
| 00850025268370 | Vitrea Advanced Visualization | 7.16.3.SU01 | 2025-09-24 | |
| 00850025268349 | Vitrea Advanced Visualization | 7.16.3 | 2025-07-11 | |
| 00850025268363 | Vitrea Advanced Visualization | 7.16.0.SU05 | 2025-06-03 | |
| 00850025268356 | Vitrea Advanced Visualization | 7.16.2.SU02 | 2025-05-23 | |
| 00850025268332 | Vitrea Advanced Visualization | 7.16.2.SU01 | 2025-05-16 | |
| 00850025268318 | Vitrea Advanced Visualization | 7.16.2 | 2025-03-21 | |
| 00850025268325 | Vitrea Advanced Visualization | 7.16.0.SU04 | 2024-11-21 | |
| 00850025268301 | Vitrea Advanced Visualization | 7.16.0.SU03 | 2024-09-20 | |
| 00850025268295 | Vitrea Advanced Visualization | 7.16.0.SU02 | 2024-08-13 | |
| 00850025268240 | Vitrea Advanced Visualization | 7.16.0.SU01 | 2024-05-02 | |
| 00850025268233 | Vitrea Advanced Visualization | 7.16.0 | 2024-04-12 | |
| 00850025268226 | Vitrea Advanced Visualization | 7.15.8.SU01 | 2024-01-29 | |
| 00850025268219 | Vitrea Advanced Visualization | 7.15.8 | 2023-10-13 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| B745ELUCIDB1P1 | Elucid Plaque-IQ | ELUCID BIOIMAGING INC. | LLZ | 2026-10-29 |
| 04719878712002 | OOOPDS | Taiwan Main Orthopaedic Biotechnology Co., Ltd. | LLZ | 2026-10-28 |
| 00889024671270 | ROSA® Hip | Orthosoft Inc | LLZ | 2026-10-27 |
| 00889024705999 | Navitracker | Orthosoft Inc | LLZ | 2026-10-26 |
| 05420060351235 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351242 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351259 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351266 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351273 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351280 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351297 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351303 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351310 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351327 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351334 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351341 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351358 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351365 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351372 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351389 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351396 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| 05420060351402 | TRUMATCH | Materialise NV | LLZ | 2026-10-22 |
| B621ICOBRAINCTP1X7Y0 | icobrain ctp | icometrix NV | LLZ | 2026-10-22 |
| 00850631008919 | Roentgen Works | Brit Systems, LLC | LLZ | 2026-10-21 |
| 00850631008926 | Roentgen Works | Brit Systems, LLC | LLZ | 2026-10-21 |
| 05420060351228 | TruMatch CMF Titanium 3D Printed Splints | Materialise NV | LLZ | 2026-10-20 |
| TKRL0001F1540 | PointCloud Knee Instruments | Unik Orthopedics Inc. | LLZ | 2026-10-20 |
| TKRL0001F1B80 | PointCloud Knee Instruments | Unik Orthopedics Inc. | LLZ | 2026-10-20 |
| TKRL0001F34K0 | PointCloud Knee Instruments | Unik Orthopedics Inc. | LLZ | 2026-10-20 |
| TKRL0001F6000 | PointCloud Knee Instruments | Unik Orthopedics Inc. | LLZ | 2026-10-20 |