DTX Studio™ Clinic 300851
GUDID 07332747199796
DTX Studio Clinic 3.2 for Mac limited
Nobel Biocare AB
Radiology DICOM image processing application software| Primary Device ID | 07332747199796 |
| NIH Device Record Key | 47f3abae-9807-4647-bf19-24ddfc5671cb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTX Studio™ Clinic |
| Version Model Number | 3.2_L |
| Catalog Number | 300851 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| 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 | 07332747199796 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K213562
FDA Product Code
| LLZ | System, image processing, radiological |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-07 |
| Device Publish Date | 2022-08-30 |
On-Brand Devices [DTX Studio™ Clinic]
| 07332747166408 | DTX Studio Clinic 1.6 for Mac |
| 07332747166392 | DTX Studio Clinic 1.6 for Win 64-bit |
| 07332747172997 | DTX Studio Clinic 1.7 for Mac |
| 07332747172980 | DTX Studio Clinic 1.7 for Win 64-bit |
| 07332747178425 | DTX Studio Clinic 1.8 for Mac |
| 07332747178418 | DTX Studio Clinic 1.8 for Win 64-bit |
| 07332747185775 | DTX Studio Clinic 1.9 for Mac |
| 07332747185768 | DTX Studio Clinic 1.9 for Win 64-bit |
| 07332747187045 | DTX Studio Clinic 2.4 for Mac |
| 07332747187038 | DTX Studio Clinic 2.4 for Win 64-bit |
| 07332747185850 | DTX Studio Clinic 2.3 for Mac |
| 07332747185843 | DTX Studio Clinic 2.3 for Win 64-bit |
| 07332747188097 | DTX Studio Clinic 2.5 for Mac |
| 07332747188080 | DTX Studio Clinic 2.5 for Win 64-bit |
| 07332747196344 | DTX Studio Clinic 3.1 for Mac |
| 07332747196320 | DTX Studio Clinic 3.1 for Win 64-bit |
| 07332747199802 | DTX Studio Clinic 3.2 for Win 64-bit limited |
| 07332747199796 | DTX Studio Clinic 3.2 for Mac limited |
| 07332747200881 | DTX Studio Clinic 3.3 for Win 64-bit limited |
| 07332747200867 | DTX Studio Clinic 3.3 for Mac limited |
| 07332747199789 | DTX Studio Clinic 3.3 for Win 64-bit |
| 07332747199772 | DTX Studio Clinic 3.3 for Mac |
| 07332747200584 | DTX Studio Clinic 3.4 for Win 64-bit |
| 07332747200577 | DTX Studio Clinic 3.4 for Mac |
| 07332747202854 | DTX Studio Clinic 4.2 for Mac |
| 07332747202830 | DTX Studio Clinic 4.2 for Win 64-bit |
| 07332747215229 | DTX Studio Clinic 4.3 for Mac |
| 07332747215212 | DTX Studio Clinic 4.3 for Win 64-bit |
Trademark Results [DTX Studio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DTX STUDIO 79205188 5537635 Live/Registered |
Nobel Biocare Services AG 2016-12-22 |
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