FDA.reportPublic FDA data

THiA

Primary DI
00754016215018
Brand
THiA
Company
Perimeter Medical Imaging AI, Inc.
Model
PMI001OCT21
Catalog number
ASY-2000
Device description
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.
Published
2021-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NQQSystem, Imaging, Optical Coherence Tomography (Oct)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQQSystem, Imaging, Optical Coherence Tomography (Oct)Radiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203578000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203578000OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc.2021-02-25NQQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754016215015PackageGS11In Commercial Distribution
00754016215018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075401621501510754016215015
00754016215018007540162150187540162150180754016215018

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological optical coherence tomography systemAn assembly of devices designed to use a broad-bandwidth light beam aimed via an applicator at a region of interest (ROI) on the surface of the skin for optical coherence tomography (OCT) to provide high-resolution images (e.g., above 1 micron) of the surface tissue in order to visualize skin morphology. It typically consists of a main unit with an operator's console, a computer for image storage, a hand-held or electromechanical probe (applicator), and a visual display unit (VDU). Reflected light is picked up by the probe that converts it into electrical signals. The computer and dedicated software provide cross-sectional images of the derma or two- or three-dimensional (3-D) volume scans.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-877-278-4614support@perimetermed.com

Regulatory Flags#

DUNS number
204112346
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754016215056Claire OCT SystemASY-32202026-04-08
00754016215025Specimen ImmobilizerPMI010CON21ASY-26002021-08-30
00754016215049S-Series OCTPMI001OCT21ASY-20002021-12-07
20754016215029Specimen ImmobilizerPMI010CON21ASY-26002021-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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