AccessGUDID - DEVICE: THiA (00754016215018)

GUDID

Device Identifier (DI) Information

Brand Name: THiA
Version or Model: PMI001OCT21
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ASY-2000
Company Name: Perimeter Medical Imaging AI, Inc.

Primary DI Number: 00754016215018
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204112346 *Terms of Use

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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
58074	Dermatological optical coherence tomography system	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NQQ	System, Imaging, Optical Coherence Tomography (Oct)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K203578	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 37731bb2-5f6f-472f-bc63-0fa17767eb91
Public Version Date: June 19, 2023
Public Version Number: 2
DI Record Publish Date: August 30, 2021