FDA.reportPublic FDA data

DIGITAL DIAGNOSTICS SYSTEM

Primary DI
15420045518933
Brand
DIGITAL DIAGNOSTICS SYSTEM
Company
Hologic, Inc.
Model
DIGITAL CYTOLOGY IMAGER
Catalog number
RM-ASY-18589
Device description
The Genius™ digital imager creates digital images of glass slides as part of the Genius™ digital diagnostics system.
Published
2026-10-19
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
false

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
15420045518933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551893315420045518933

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide digital imaging scanner IVDA mains electricity (AC-powered) device designed to be used in a histopathology laboratory to scan clinical specimens on microscope slides, at a microscopic level, to produce images in a digital format. Also known as a whole slide scanner or digital pathology slide scanning system, it is a bench-top unit with slide tray slots, high-resolution cameras, a user interface, and integrated software for image creation, viewing, and management to aid the pathologist to review and interpret slide images.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity00
Handling Environment Temperature00
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
018925968
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
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
15420045518452DIGITAL DIAGNOSTICS SYSTEMDIGITAL CYTOLOGY IMAGERRM-ASY-185882026-10-19
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
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045518452DIGITAL 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
15420045514201DIGITAL DIAGNOSTICS SYSTEMHologic, Inc.QYV2024-06-07