Claire OCT System

Primary DI
00754016215056
Brand
Claire OCT System
Company
Perimeter Medical Imaging AI, Inc.
Model
ASY-3220
Published
2026-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
SHHOct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SHHOct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast CancerUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P250008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P250008000Claireâ„¢ OCT SystemPerimeter Medical Imaging Ai, Inc.2026-03-03SHH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754016215053PackageGS11In Commercial Distribution
00754016215056PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075401621505310754016215053
00754016215056007540162150567540162150560754016215056

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.

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
00754016215025Specimen ImmobilizerPMI010CON21ASY-26002021-08-30
00754016215049S-Series OCTPMI001OCT21ASY-20002021-12-07
00754016215018THiAPMI001OCT21ASY-20002021-08-30
20754016215029Specimen ImmobilizerPMI010CON21ASY-26002021-08-30