FDA.reportPublic FDA data

Second Opinion

Primary DI
00860003567920
Brand
Second Opinion
Company
Pearl Inc.
Model
2
Published
2025-01-10
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
MYNAnalyzer, Medical Image

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MYNAnalyzer, Medical ImageRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210365000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210365000Second OpinionPearl, Inc.2022-03-04MYN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003567920PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003567920008600035679208600035679200860003567920

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118187332
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003567944Second Opinion 3D1.x2025-12-12
00198715016079Second Opinion2.x2025-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262352357935DS Core DetectZetta25 AGMYN2026-06-03
00852491008047ChestSuiteImagen Technologies, Inc.MYN2026-04-15
00860015071101SugarBotBENCH7 INC.MYN2026-04-08
07332747236620DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
07332747236637DTX Studio™ ClinicNobel Biocare ABMYN2026-03-27
08801643467098NASamsung Electronics Co., Ltd.MYN2026-03-17
00860010268063DiagnocatDGNCT LLCMYN2026-01-29
07332747221855DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
07332747221862DTX Studio™ AssistNobel Biocare ABMYN2025-12-01
07332747225501DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
07332747225518DTX Studio™ ClinicNobel Biocare ABMYN2025-10-06
00198715016079Second OpinionPearl Inc.MYN2025-07-31
M722X25122C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XC25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
M722XD25114C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-06-17
07332747221183DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
07332747221190DTX Studio™ ClinicNobel Biocare ABMYN2025-04-24
08908023670038DeepTek CXR AnalyzerDEEPTEK MEDICAL IMAGING PRIVATE LIMITEDMYN2025-04-24
03770020839092ChestView USGLEAMERMYN2025-04-02
M722X25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XC25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
M722XD25064C250640ClearRead Xray DetectRiverain Technologies, Inc.MYN2025-03-27
07332747219616DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
07332747219623DTX Studio™ ClinicNobel Biocare ABMYN2025-01-26
00860010893203Velmeni for DentistsVelmeni Inc.MYN2024-12-11
00860005586318Overjet Caries AssistOverjet, Inc.MYN2024-11-12
00860005586325Overjet Calculus AssistOverjet, Inc.MYN2024-11-12
00860005586332Overjet Periapical Radiolucency AssistOverjet, Inc.MYN2024-11-12
00860005586363Overjet Caries Assist-PediatricOverjet, Inc.MYN2024-11-12
B630QVCS346QVCAD SystemQVIEW MEDICALMYN2024-06-26