Dolphin Imaging
GUDID 00350227500006
DI Vers 11.95 PRE
Dolphin Imaging MGT Solutions
Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiology PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software Radiological PACS software| Primary Device ID | 00350227500006 |
| NIH Device Record Key | 2f48c6fa-8613-4945-9996-481a6d3915f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dolphin Imaging |
| Version Model Number | 11.95 |
| Company DUNS | 966628005 |
| Company Name | Dolphin Imaging MGT Solutions |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00350227500006 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K110430
FDA Product Code
| LLZ | System, Image Processing, Radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-05-23 |
| Device Publish Date | 2017-10-31 |
On-Brand Devices [Dolphin Imaging]
| 00350227500044 | DI DLS |
| 00350227500037 | DI Vers 11.95 PF KYLS |
| 00350227500020 | DI Vers 11.95 PF |
| 00350227500013 | DI Vers 11.95 PRE KYLS |
| 00350227500006 | DI Vers 11.95 PRE |
Trademark Results [Dolphin Imaging]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DOLPHIN IMAGING 98416945 not registered Live/Pending |
Patterson Companies, Inc. 2024-02-22 |
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