PEARL INC.

FDA Device Registration & Listing · West Hollywood, CA, US · Registration 3021887566

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3021887566
FEI Number
3021887566
Entity Name
PEARL INC.
City/State/Country
West Hollywood, CA, US
Establishment Address
9200 W Sunset Blvd Ste 430, West Hollywood, CA 90069, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Pearl Inc. (Owner Number: 10084584)
Owner / Operator Contact Address
9200 Sunset Blvd, Suite 430, West Hollywood, CA 90069, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K243230
PMA Number
N/A

All Registered Proprietary Names

Second Opinion Second Opinion CC Second Opinion Pediatric Second Opinion Second Opinion Panoramic Second Opinion CS Second Opinion Second Opinion Second Opinion Second Opinion Periapical Radiolucency Contours Second Opinion 3D Second Opinion Second Opinion BLE

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-06-30
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-06-30
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-12-11
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-06-30
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2022-03-09
MYN Analyzer, Medical Image Radiology Class 2 892.2070 2025-06-30
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-06-30
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-06-30

Official Correspondent

Ashley Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pearl Inc.
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
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021887566. Last updated year: 2026. Please use registration number 3021887566 when referencing this establishment in official correspondence.
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