Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013276158

FEI Number

3013276158

Entity Name

PERIMETER MEDICAL IMAGING AI, INC.

City/State/Country

Toronto Ontario, CA

Establishment Address

555 Richmond St W, Suite 511, Toronto Ontario M5V 3B1, CA

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Perimeter Medical Imaging AI (Owner Number: 10052944)

Owner / Operator Contact Address

555 Richmond St W, Suite 511, Toronto, CA-ON M5V 3B1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K203578

PMA Number

N/A

All Registered Proprietary Names

Perimeter S-Series OCT Perimeter OTIS 2.1 Optical Coherence Tomography System THiA

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2021-03-01

Official Correspondent

Emily Campbell

US Agent Details

Sara Brien Business: Perimeter Medical Imaging AI Email: sbrien@perimetermed.com Phone: (650) 7889246

Related Public Records

Same Entity

Perimeter Medical Imaging AI

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K183320	St. Jude Medical (Now Abbott Medical)	Ilumien Optis, Optis Integrated, Optis Mobile	2019-04-02
K253459	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)	2026-04-24
K210458	ABBOTT MEDICAL	OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System	2021-06-08

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013276158. Last updated year: 2026. Please use registration number 3013276158 when referencing this establishment in official correspondence.