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.

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• 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
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: support@perimetermed.com
• Phone: 1-877-278-4614
• Email: 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