Last synced on 23 September 2022 at 11:05 pm

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203578
510(k) Type
Special
Applicant
Perimeter Medical Imaging AI, Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/25/2021
Days to Decision
80 days
Submission Type
Summary

OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203578
510(k) Type
Special
Applicant
Perimeter Medical Imaging AI, Inc.
Country
Canada
FDA Decision
Substantially Equivalent
Decision Date
2/25/2021
Days to Decision
80 days
Submission Type
Summary