S-Series OCT ASY-2000

GUDID 00754016215049

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 Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system Dermatological optical coherence tomography system
Primary Device ID00754016215049
NIH Device Record Keyb9ec1c73-c8f6-4a47-b9cb-42a1a3953d55
Commercial Distribution StatusIn Commercial Distribution
Brand NameS-Series OCT
Version Model NumberPMI001OCT21
Catalog NumberASY-2000
Company DUNS204112346
Company NamePerimeter Medical Imaging AI, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com
Phone1-877-278-4614
Emailsupport@perimetermed.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100754016215049 [Primary]
GS110754016215046 [Package]
Package: Single Unit Package [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-15
Device Publish Date2021-12-07

Devices Manufactured by Perimeter Medical Imaging AI, Inc.

00754016215049 - S-Series OCT2021-12-15The 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.
00754016215049 - S-Series OCT2021-12-15 The OTIS 2.1 Optical Coherence Tomography System is indicated for use as an imaging tool in the evaluation of excised human tiss
00754016215018 - THiA2021-09-07 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 Immobilizer2021-09-07 The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumabl
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