FDA.reportPublic FDA data

Envision

Primary DI
15420045516342
Brand
Envision
Company
Hologic, Inc.
Model
ASY-15637
Catalog number
ASY-15637
Published
2025-11-13
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
OTEDigital breast tomosynthesis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OTEDigital Breast TomosynthesisUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045516342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551634215420045516342

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
139534114
Device count
1
Lot or batch
true
Manufacturing date on label
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
15420045515796EnvisionHologic, Inc.OTE2026-10-09
15420045515802EnvisionHologic, Inc.OTE2026-10-09
15420045515864EnvisionHologic, Inc.OTE2026-10-09
15420045515871EnvisionHologic, Inc.OTE2026-10-09
15420045515895EnvisionHologic, Inc.OTE2026-10-09
15420045517462EnvisionHologic, Inc.OTE2026-10-09
15420045517479EnvisionHologic, Inc.OTE2026-10-09
15420045518131Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518148Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518155Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518162Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518179Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518186Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518193Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518216Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518223Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
15420045518230Selenia® Dimensions®Hologic, Inc.OTE2026-03-12
00198953109281Senographe PristinaGE MEDICAL SYSTEMSOTE2025-12-01
10198953054311not applicableGE MEDICAL SYSTEMSOTE2025-11-28
15420045516236EnvisionHologic, Inc.OTE2025-11-13
15420045516243EnvisionHologic, Inc.OTE2025-11-13
15420045516250EnvisionHologic, Inc.OTE2025-11-13
15420045516267EnvisionHologic, Inc.OTE2025-11-13
15420045516274EnvisionHologic, Inc.OTE2025-11-13
15420045516281EnvisionHologic, Inc.OTE2025-11-13
15420045516304EnvisionHologic, Inc.OTE2025-11-13
15420045516311EnvisionHologic, Inc.OTE2025-11-13
15420045516328EnvisionHologic, Inc.OTE2025-11-13
15420045516335EnvisionHologic, Inc.OTE2025-11-13
15420045516359EnvisionHologic, Inc.OTE2025-11-13