Affirm Prone Breast Biopsy Guidance System Package Inserts/IFUs

Affirm Prone Breast Biopsy Guidance System Package Inserts/IFUs

Submitted by holx-admin on Wed, 12/06/2017 - 14:30
US
Part # Document name Document Type Country-Language Document Revision Files Valid Date (YYYY-MM)

Master Terms and Conditions

Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)
Hologic
Hologic Master Terms and Sales Conditions
US-English
Master Sales Terms and Conditions US 06.11.2015.pdf168.48 KB

Cyber Security

Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)
CTB-00668 Rev 001 - Cybersecurity Landing Page on Hologic.com
English (US)
CTB-00668 Rev 001 - Cybersecurity Landing Page on Hologic.com__0.pdf237.39 KB
Patch Release AFFIRM PRONE Windows 10 January 2020
English (US)
Patch Release AFFIRM PRONE Win10 January 2020.pdf172.29 KB
Patch Release AFFIRM PRONE Windows 7 January 2020
English (US)
Patch Release AFFIRM PRONE Win7 January 2020.pdf115.09 KB
Patch Release AFFIRM PRONE Win10 December 2019
English (US)
Patch Release AFFIRM PRONE Win10 December 2019.pdf159.49 KB
Patch Release AFFIRM PRONE Win7 December 2019
English (US)
Patch Release AFFIRM PRONE Win7 December 2019.pdf116.47 KB
Patch Release AFFIRM PRONE Win10 NOVEMBER 2019
English (US)
Patch Release AFFIRM PRONE Win10 NOVEMBER 2019.pdf160.22 KB
Patch Release AFFIRM PRONE Win7 NOVEMBER 2019
English (US)
Patch Release AFFIRM PRONE Win7 NOVEMBER 2019.pdf117.16 KB
Patch Release AFFIRM PRONE Win10 OCTOBER 2019
English (US)
Patch Release AFFIRM PRONE Win10 OCTOBER 2019.pdf160.75 KB
Patch Release AFFIRM PRONE Win7 OCTOBER 2019
English (US)
Patch Release AFFIRM PRONE Win7 OCTOBER 2019.pdf162.06 KB
Patch Release AFFIRM PRONE Win10 SEPTEMBER 2019
English (US)
Patch Release AFFIRM PRONE Win10 SEPTEMBER 2019.pdf160.31 KB
Patch Release AFFIRM PRONE Win7 SEPTEMBER 2019
English (US)
Patch Release AFFIRM PRONE Win7 SEPTEMBER 2019.pdf161.21 KB
Patch Release AFFIRM PRONE Win10 AUGUST 2019
English (US)
Patch Release AFFIRM PRONE Win10 AUGUST 2019_0.pdf161.48 KB
Patch Release AFFIRM PRONE Win7 AUGUST 2019
English (US)
Patch Release AFFIRM PRONE Win7 AUGUST 2019_0.pdf162.73 KB
Patch Release AFFIRM PRONE July 2019
English (US)
Patch Release AFFIRM PRONE July 2019.pdf143.53 KB
Patch Release AFFIRM PRONE June 2019
English (US)
Patch Release AFFIRM PRONE June 2019.pdf143.11 KB
Patch Release AFFIRM PRONE May 2019 (contains KB4499175 patch for CVE-2019-0708)
English (US)
Patch Release AFFIRM PRONE May 2019.pdf142.44 KB
Patch Release AFFIRM PRONE APRIL 2019
English (US)
Patch Release AFFIRM PRONE APRIL 2019.pdf157.28 KB
Patch Release AFFIRM PRONE March 2019
English (US)
Patch Release AFFIRM PRONE March 2019.pdf156.73 KB
Patch Release AFFIRM PRONE February 2019
English (US)
Patch Release AFFIRM PRONE February 2019.pdf157.39 KB
Patch Release AFFIRM PRONE January 2019
English (US)
Patch Release AFFIRM PRONE January 2019.pdf156.94 KB
Patch Release AFFIRM PRONE December 2018
English (US)
Patch Release AFFIRM PRONE December 2018.pdf157.2 KB
Patch Release AFFIRM PRONE November 2018
English (US)
Patch Release AFFIRM PRONE November 2018.pdf54.75 KB
Patch Release AFFIRM PRONE October 2018
English (US)
Patch Release AFFIRM PRONE October 2018.pdf54.67 KB
Patch Release AFFIRM PRONE September 2018
English (US)
Patch Release AFFIRM PRONE September 2018.pdf54.55 KB
Patch Release AFFIRM PRONE August 2018
English (US)
Patch Release AFFIRM PRONE August 2018.pdf54.61 KB
Patch Release AFFIRM PRONE July 2018
English (US)
Patch Release AFFIRM PRONE July 2018.pdf54.86 KB
Patch Release AFFIRM PRONE June 2018
US (English)
Patch Release AFFIRM PRONE June 2018.pdf54.56 KB
Patch Release AFFIRM PRONE May 2018
US-English
Patch Release AFFIRM PRONE May 2018.pdf54.8 KB
Patch Release AFFIRM PRONE April 2018
US-English
Patch Release AFFIRM PRONE April 2018.pdf54.78 KB
Patch Release AFFIRM PRONE March 2018
US-English
Patch Release AFFIRM PRONE March 2018.pdf54.33 KB
MAN-00363 Revision 006
Enterprise Cybersecurity Best Practices Guide
US-English
Enterprise Cybersecurity Best Practices Guide (MAN-00363) English Rev_006 04_13.pdf1.51 MB

Manufacturer Disclosure Statement for Medical Device Security (MDS2) Sheets

Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)
MAN-05009 Revision 002
Affirm Prone Biopsy Guidance System v1.1 MDS2 Sheet
US-English
Affirm Prone Biopsy v1.1 MDS2 Sheet (MAN-05009) English Rev_002 09-2020.pdf277.67 KB

DICOM Conformance Statements

Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)
MAN-06084 Revision 001
Affirm Prone Breast Biopsy Guidance System v1.1 DICOM Conformance Statement
US-English
Affirm Prone v1.1 DICOM Conformance Statement (MAN-06084) English Rev_001 11-2019.pdf1.9 MB
MAN-04705 Rev. 002
Affirm Prone Biopsy Guidance System v1.0 DICOM Conformance Statement
US-English
Affirm Prone Biopsy v1.0 DICOM Conformance Statement (MAN-04705) English Rev_002 12-2019.pdf1.93 MB
MAN-04705 Revision 001
Affirm Prone v1.0 DICOM Conformance Statement
US-English
Affirm Prone v1.0 DICOM Conformance Statement (MAN-04705) English 01_16.pdf1.73 MB

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Worldwide
Part # Document name Document Type Country-Language Document Rev Files Valid Date (YYYY-MM)
Hologic Canada
Hologic Master Terms and Sales Conditions- Canadian Customers
US-English
Hologic_Master_Sales_TCs-9-10-12(can).PDF72.03 KB

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