FDA.reportPublic FDA data

DIGITAL DIAGNOSTICS SYSTEM

Primary DI
15420045517097
Brand
DIGITAL DIAGNOSTICS SYSTEM
Company
Hologic, Inc.
Model
ASSEMBLY, REVIEW STATION COMPUTER
Catalog number
ASY-14304
Device description
Computer to operate the Genius™ Review Station.
Published
2025-07-17
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
15420045517097PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551709715420045517097

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 Temperature10 Degrees Celsius35 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 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
25420045516691RESPDIRECT™RESPDIRECT COLLECTION KIT, US-KIT, BOXPRD-077882023-08-14
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
15420045500372ProcleixUltrio Plus 1K3025732014-08-06
15420045500389ProcleixUltrio Plus 1K3025732014-08-06
15420045500396ProcleixUltrio Plus 1K3025732014-08-06
15420045500402ProcleixUltrio Plus 1K3025732014-08-06
15420045500419ProcleixUltrio Plus 5K3025742014-08-06
15420045500426ProcleixUltrio Plus 5K3025742014-08-06
15420045500433ProcleixUltrio Plus 5K3025742014-08-06
15420045500440ProcleixUltrio Plus 5K3025742014-08-06
15420045500457ProcleixUltrio Plus 5K3025742014-08-06
15420045500464ProcleixUltrio Plus, HIV-1 D-Probes3025712014-08-06
15420045500471ProcleixUltrio Plus HBV D-Probes3025762014-08-06
15420045500488ProcleixUltrio Plus HCV D-Probes3025772014-08-06
15420045500495ProcleixUltrio Plus TIGRIS Controls3025722014-08-06
15420045500501ProcleixUltrio Plus Calibrators3025752014-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
15420045514201DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07