Faxitron CT FAX-019

GUDID 15420045514911

Hologic, Inc.

Specimen x-ray system IVD
Primary Device ID15420045514911
NIH Device Record Keyc0e1d56f-ed90-4762-8bbf-6be26cd16131
Commercial Distribution StatusIn Commercial Distribution
Brand NameFaxitron CT
Version Model NumberVISION CT
Catalog NumberFAX-019
Company DUNS139534114
Company NameHologic, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS115420045514911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWPCabinet, x-ray system

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-15
Device Publish Date2021-10-07

Devices Manufactured by Hologic, Inc.

25420045500874 - TLiIQ System2024-08-15 System that detects fFN in cervicovaginal secretions.
15420045516212 - Fluent Pro Fluid Management System2024-08-14 The Fluent Pro Fluid Management System is intended to provide liquid distension of the uterus during diagnostic and operative hy
15420045510470 - Panther Fusion®2024-07-22 Panther Fusion® Internal Control-X.
15420045510890 - Panther Fusion®2024-07-22 The Panther Fusion® GBS assay is an automated qualitative in vitro diagnostic test utilizing realtime PCR for detection of Grou
15420045510548 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510555 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas
15420045510562 - 3Dimensions2024-07-08 Selenia® Dimensions® Mobile digital mammography system is a mobile mammographic system used for capturing digital x-ray image
15420045510579 - 3Dimensions2024-07-08 Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breas

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.