S-Series OCT ASY-2000

GUDID 00754016215049

Dermatological optical coherence tomography system

Primary Device ID	00754016215049
NIH Device Record Key	b9ec1c73-c8f6-4a47-b9cb-42a1a3953d55
Commercial Distribution Status	In Commercial Distribution
Brand Name	S-Series OCT
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

Device Issuing Agency	Device ID
GS1	00754016215049 [Primary]
GS1	10754016215046 [Package] Package: Single Unit Package [1 Units] In Commercial Distribution

NQQ	System, Imaging, Optical Coherence Tomography (Oct)

Steralize Prior To Use	false
Device Is Sterile	false

00754016215049 - S-Series OCT	2021-12-15The 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 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	2021-09-07 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