THiA ASY-2000
GUDID 00754016215018
The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor.
Perimeter Medical Imaging AI, Inc.
Dermatological optical coherence tomography system| Primary Device ID | 00754016215018 |
| NIH Device Record Key | 37731bb2-5f6f-472f-bc63-0fa17767eb91 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | THiA |
| Version Model Number | PMI001OCT21 |
| Catalog Number | ASY-2000 |
| Company DUNS | 204112346 |
| Company Name | Perimeter Medical Imaging AI, Inc. |
| 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 | false |
| Serial Number | true |
| 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
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com | |
| Phone | 1-877-278-4614 |
| support@perimetermed.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00754016215018 [Primary] |
| GS1 | 10754016215015 [Package] Package: Single unit package [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203578
FDA Product Code
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) |
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 | 2021-09-07 |
| Device Publish Date | 2021-08-30 |
Devices Manufactured by Perimeter Medical Imaging AI, Inc.
| 00754016215049 - S-Series OCT | 2021-12-15 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss |
| 00754016215018 - THiA | 2021-09-07The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. Perimeter’s OTIS 2.1 cart assembly encloses an OCT-based imaging system and has a touchscreen monitor. |
| 00754016215018 - THiA | 2021-09-07 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss |
| 20754016215029 - Specimen Immobilizer | 2021-09-07 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumabl |
Trademark Results [THiA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THIA 98533188 not registered Live/Pending |
Nsiah, Berthia 2024-05-03 |
 THIA 90069267 not registered Live/Pending |
Perimeter Medical Imaging, Inc. 2020-07-23 |
 THIA 87595781 not registered Dead/Abandoned |
Maly, Dusan 2017-09-05 |
 THIA 86119854 not registered Live/Pending |
MANTAB INC. 2013-11-15 |
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