FDA.reportPublic FDA data

DIGITAL DIAGNOSTICS SYSTEM

Primary DI
15420045514201
Brand
DIGITAL DIAGNOSTICS SYSTEM
Company
Hologic, Inc.
Model
DISPLAY, 27IN, 8MP
Catalog number
CMP-01669
Device description
Medical grade Genius™ Review Station monitor for use with the Genius™ Digital Diagnostics System.
Published
2024-06-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QYVDigital cervical cytology slide imaging system with artificial intelligence algorithm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence AlgorithmPathology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN210035000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN210035000“Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm”Hologic, Inc.2024-01-31QYV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045514201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551420115420045514201

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius32 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15420045518452DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185882026-10-19
15420045518933DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185892026-10-19
00850346007030CoolSeal™ TrinityCSL-TR105-30CSL-TR105-302020-10-13
00850346007047CoolSeal™ TrinityCSL-TR105-37CSL-TR105-372020-10-13
00850346007061CoolSeal™ TrinityCSL-TR105-44CSL-TR105-442020-10-13
00850346007092CoolSeal™ RevealCSL-RV105-10CSL-RV105-102021-05-19
00850346007085CoolSeal™ MiniCSL-MN103-20CSL-MN103-202020-10-13
00850346007023CoolSeal™ GeneratorCSL-200-50CSL-200-502020-10-13
15420045515796EnvisionEnvision System Software LicenseCMP-019182026-10-09
15420045515802EnvisionEnvision Tomosynthesis LicenseCMP-029192026-10-09
15420045515864EnvisionEnvision Tomo Synthesized 2D LicenseCMP-019212026-10-09
15420045515871EnvisionEnvision 3DQorum LicenseCMP-019222026-10-09
15420045515895EnvisionEnvision SmartCurve Paddle LicenseCMP-019242026-10-09
15420045517462EnvisionENV-SYS-STDENV-SYS-STD2026-10-09
15420045517479EnvisionENV-SYS-STD-NSENV-SYS-STD-NS2026-10-09
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045518452DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2026-10-19
15420045518933DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2026-10-19
15420045517097DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2025-07-17
15420045517585DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2025-04-03
15420045513877DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513884DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513907DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513914DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513921DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07
15420045513976DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07