Envision ASY-15786

GUDID 15420045516359

Hologic, Inc.

Radiological breast positioner, non-wearable

• Primary Device ID: 15420045516359
• NIH Device Record Key: f0bf9667-a797-47db-9f39-9fc9539390d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Envision
• Version Model Number: ASY-15786
• Catalog Number: ASY-15786
• Company DUNS: 139534114
• Company Name: Hologic, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com
• Phone: +1(800)442-9892
• Email: CustomerSupport@hologic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	15420045516359 [Primary]

FDA Product Code

• OTE: Digital breast tomosynthesis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-21
• Device Publish Date: 2025-11-13

On-Brand Devices [Envision]

• 15420045516465: ASY-16152
• 15420045516458: ASY-16151
• 15420045516441: ASY-16150
• 15420045516434: ASY-15794
• 15420045516427: ASY-15793
• 15420045516410: ASY-15792
• 15420045516403: ASY-15791
• 15420045516397: ASY-15790
• 15420045516380: ASY-15789
• 15420045516373: ASY-15788
• 15420045516366: ASY-15787
• 15420045516359: ASY-15786
• 15420045516342: ASY-15637
• 15420045516335: ASY-14631
• 15420045516328: ASY-14630
• 15420045516311: ASY-14628
• 15420045516304: ASY-14627
• 15420045516281: ASY-14626
• 15420045516274: ASY-14625
• 15420045516267: ASY-14624
• 15420045516250: ASY-14623
• 15420045516243: ASY-14622
• 15420045516236: ASY-14621