FDA.reportPublic FDA data

Specimen Immobilizer

Primary DI
20754016215029
Brand
Specimen Immobilizer
Company
Perimeter Medical Imaging AI, Inc.
Model
PMI010CON21
Catalog number
ASY-2600
Device description
The OTIS 2.1 system includes a single-use specimen container, the Consumable Set, that facilitates tissue imaging. The consumable set consists of a Specimen Tray and Specimen Lid. The Specimen Tray engages with the device to initiate scanning and the Specimen Lid facilitates engaging vacuum to enable vacuum assisted specimen positioning during image acquisition.
Published
2021-08-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
20754016215029PackageGS110In Commercial Distribution
00754016215025PrimaryGS10
00754016215032Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2075401621502920754016215029
00754016215025007540162150257540162150250754016215025
00754016215032007540162150327540162150320754016215032

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
1-877-278-4614contact@perimetermed.com

Regulatory Flags#

DUNS number
204112346
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00754016215018THiAPMI001OCT21ASY-20002021-08-30

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Primary DI, Brand, Company table
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