Affirm Prone Breast Biopsy Guidance System Package Inserts/IFUs
Part # Hologic
Hologic Master Terms and Sales Conditions
File: Master Sales Terms and Conditions US 06.11.2015.pdf
Country-Language: US-English
Cyber Security
Part # CTB-00668
Cybersecurity Landing Page on Hologic.com
File: CTB-00668 Rev 001 – Cybersecurity Landing Page on Hologic.com__0.pdf
Country-Language: US-English
Document type: Customer Technical Bulletin
Document Revision: 001
Manufacturer Disclosure Statement for Medical Device Security (MDS2) Sheets
Part # MAN-05009 Revision 002
Affirm Prone Biopsy Guidance System v1.1 MDS2 Sheet
File: Affirm Prone Biopsy v1.1 MDS2 Sheet (MAN-05009) English Rev_002 09-2020.pdf
Country-Language: US-English
DICOM Conformance Statements
Part # MAN-10538
Affirm Prone Breast Biopsy Guidance System v1.1 DICOM Conformance Statement
File: Affirm Prone Breast Biopsy Guidance System v1.1 DICOM Conformance Statement (MAN-10538) Rev_001 09-2023.pdf
Country-Language: US-English
Valid Date: From:
Document type: DICOM Conformance Statement
Document Revision: 001
Part # MAN-06084 Revision 001
Affirm Prone Breast Biopsy Guidance System v1.1 DICOM Conformance Statement
File: Affirm Prone v1.1 DICOM Conformance Statement (MAN-06084) English Rev_001 11-2019.pdf
Country-Language: US-English
Part # MAN-10895
Affirm Prone Breast Biopsy Guidance System v1.0 DICOM Conformance Statement
File: Affirm Prone Breast Biopsy Guidance System v1.0 DICOM Conformance Statement (MAN-10895) Rev_001 09-2023.pdf
Country-Language: US-English
Valid Date: From:
Document type: Conformance Statement
Document Revision: 001
Part # MAN-04705 Rev. 002
Affirm Prone Biopsy Guidance System v1.0 DICOM Conformance Statement
File: Affirm Prone Biopsy v1.0 DICOM Conformance Statement (MAN-04705) English Rev_002 12-2019.pdf
Country-Language: US-English
Part # MAN-04705 Revision 001
Affirm Prone v1.0 DICOM Conformance Statement
File: Affirm Prone v1.0 DICOM Conformance Statement (MAN-04705) English 01_16.pdf
Country-Language: US-English
Part # CBT-00668
Cybersecurity Landing Page on Hologic.com
File: CTB-00668 Rev 001 – Cybersecurity Landing Page on Hologic.com_.pdf
Country-Language: US-English
Valid Date: From:
Part # CBT-00668
Cybersecurity Landing Page on Hologic.com
File: CTB-00668 Rev 001 – Cybersecurity Landing Page on Hologic.com_.pdf
Country-Language: US-English
Valid Date: From:
Instructions for Use
Part # MAN-11094
Affirm Prone Breast Biopsy Guidance System Instructions for Solid Center Pad
File: Affirm Prone Breast Biopsy Guidance System Instructions for Solid Center Pad on the Affirm Prone Biopsy System (MAN-11094) Rev_001 10-2023.pdf
Country-Language: US-English
Valid Date: 2023-10
Part # MAN-11496
Affirm Prone Breast Biopsy Guidance System Equipment Drape Set
File: Affirm Prone Breast Biopsy Guidance System Equipment Drape Set (MAN-11496) Rev_001 06-2024.pdf
Country-Language: US-English
Valid Date: 2024-06
Part # MAN-10564
Affirm Prone 1.1 Customer Release Notes (NWK)
File: Affirm Prone 1.1 Customer Release Notes (MAN-10564) Rev_001 02-20024.pdf
Country-Language: US-English
Valid Date: 2024-02
Part # MAN-10923
Affirm Prone 1.0.2 Customer Release Notes (NWK)
File: Affirm Prone 1.0.2 Customer Release Notes (NWK) (MAN-10923) Rev_001 02-20024.pdf
Country-Language: US-English
Valid Date: 2024-02
Part # MAN-06480-002 Revision 001
Addendum, European Commission Authorized Representative Change
File: Addendum, European Commission Authorized Representative Change (MAN-06480-002) English Rev_001 09-2019_1.pdf
Country-Language: US-English
Part # MAN-10552
Affirm Prone Breast Biopsy Guidance System Account Management After APBS v1.1 Upgrade User Instructions
File: Affirm Prone Breast Biopsy Guidance System Account Management After APBS v1.1 Upgrade User Instructions (MAN-10552) Rev_001 09-2023.pdf
Country-Language: US-English
Past Revisions of User Instructions
Part # MAN-05652 Revision 001
Affirm Prone Biopsy Equipment Drape Kit User Instruction
File: Affirm Prone Biopsy Equipment Drape Kit User Instruction (MAN-05652) English Rev_001 05-2018.pdf
Country-Language: US-English
Part # MAN-10530
Affirm Prone Breast Biopsy Guidance System Equipment Drape Set User Instructions
File: Affirm Prone Breast Biopsy Guidance System Equipment Drape Set User Instructions (MAN-10530) Rev_001 09-2023.pdf
Country-Language: US-English
Valid Date:
Part # MAN-05101 Revision 001
Affirm Prone breast biopsy guidance system Drape Set User Installation
File: Affirm Prone Drape Set User Installation (MAN-05101) English Rev_001 11_16.pdf
Country-Language: US-English
Part # MAN-06507-002 Rev. 001
Affirm Prone Biopsy Guidance System v1.0 User Guide
File: Affirm Prone Biopsy v1.0 User Guide (MAN-06507-002) English Rev_001 09-2019.pdf
Country-Language: US-English
Part # MAN-04480 Revision 004
Affirm Prone breast biopsy guidance system v1.0 User Guide
File: Affirm Prone v1.0 User Guide (MAN-04480) English Rev 004 06_18.pdf
Country-Language: US-English
Part # MAN-05069 Rev. 002
Affirm Prone Breast Biopsy Guidance System Mobile Transport Quick Reference Guide
File: Affirm Prone Biopsy v1.0 Mobile Transport Quick Reference Guide (MAN-05069) English Rev_002 12-2019.pdf
Country-Language: US-English