Dolphin Imaging
GUDID 00350227500006
DI Vers 11.95 PRE
Dolphin Imaging MGT Solutions
Radiology 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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