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HOLOGIC INC

AFFIRM · Radiology

510(k): 3 Recall: 1 UDI: 27 MAUDE: 10 Class.: 60

510(k) Clearances (3)

Affirm Contrast Biopsy

2020-10-05

Substantially Equivalent

Affirm Prone Biopsy System

2016-04-01

Substantially Equivalent

AFFIRM BREAST BIOPSY GUIDANCE SYSTEM

2011-01-07

Substantially Equivalent

Recalls (1)

Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880

2017-07-07

The firm is implementing a product correction involving its Affirm Lateral Arm Upright Biopsy Accessory, ASY-09880. The correction has been initiated due to a component (the Left-hand Guide or the Blue Needle Guide) issue that could impact needle alignment for all the left-approach lateral biopsy procedures. This may have an impact on the position of the needle within the breast, and thus on the a…

UDI Registrations (27)

Affirm Prone Biopsy System

Affirm Prone Biopsy Complete Gantry

AFFIRM™ CONTRAST BIOPSY

Affirm® breast biopsy guidance system software is designed to allow the accurate location of lesions in the breast in three dimensions. It is intended to provide guidance for interventional purposes such as biopsy, pre-surgerical localization or treatment devices.

Affirm Lateral Arm Upright Biopsy Accessory

Affirm Lateral Arm Upright Biopsy Accessory Lateral Arm Stand

Affirm Prone Biopsy System

Affirm Prone Biopsy Complete Gantry

Affirm Prone Biopsy System

PADDLE, BIOPSY, LATERAL, 15 CM

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY SYSTEM, 3D

Affirm Prone Biopsy System

HV GENERATOR

Affirm Lateral Arm Upright Biopsy Accessory

Selenia Dimensions Axillary Biopsy Paddle

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY SYSTEM, 2D

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY SYSTEM, 2D

Affirm Lateral Arm Upright Biopsy Accessory

Affirm Breast Biopsy Guidance System

Selenia Dimensions Axillary Biopsy Paddle

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY SYSTEM, 3D

Affirm Breast Biopsy Guidance System

Selenia Dimensions Axillary Biopsy Paddle

Affirm Breast Biopsy Guidance System

Affirm Prone Biopsy System

AFFIRM PRONE BIOPSY ACQUISITION WORKSTATION

Affirm Prone Biopsy System

PADDLE, BIOPSY, STANDARD, 6 CM X 7 CM

Affirm Breast Biopsy Guidance System

Selenia Dimensions Axillary Biopsy Paddle

Affirm Prone Biopsy System

HV GENERATOR

AFFIRM™ SPECIMEN IMAGING

Affirm Prone Biopsy System

PADDLE, BIOPSY, AXILLA, 5 CM X 5 CM

Affirm Prone Biopsy System

PADDLE, BIOPSY, STANDARD, 5 CM X 5 CM

Affirm Prone Biopsy System

AFFIRM SYSTEM, S/W 3D LICENSE

Affirm®

Affirm Breast Biopsy Guidance System

MAUDE Adverse Events (10)

Malfunction

20211217

Malfunction

20211007

Injury

20210729

Malfunction

20210412

Injury

20210303

Untitled record

20201228

Untitled record

20201228

Injury

20201029

Malfunction

20200825

Injury

FDA Classification (60)

Processor, Cine Film

Radiology

Hydrogel Spacer

Radiology

Cassette, Measurement, Ardran-Crooks

Radiology

Assembly, Tube Housing, X-Ray, Therapeutic

Radiology

Generator, Orthovoltage, Therapeutic X-Ray

Radiology

Cabinet, X-Ray System

Radiology

Solid State X-Ray Imager (Flat Panel/Digital Imager)

Radiology

Camera, Multi Format, Radiological

Radiology

System, Imaging, Holography, Acoustic

Radiology

Film, Radiographic

Radiology

Counter, Whole Body, Nuclear

Radiology

Holder, Syringe, Lead

Radiology

Processor, Radiographic-Film, Automatic, Dental

Radiology

Camera, X-Ray, Fluorographic, Cine Or Spot

Radiology

System, Therapeutic, X-Ray

Radiology

Display, Diagnostic Radiology

Radiology

Radiation Therapy Marking Device

Radiology

Radiological Computer-Assisted Prioritization Software For Lesions

Radiology

System, Nuclear Magnetic Resonance Imaging

Radiology

Colon Computed Tomography System, Computer Aided Detection

Radiology

Instrument, Quality-Assurance, Radiologic

Radiology

Analyzer, Medical Image

Radiology

Dosimeter, Ionizing Radiation, Implanted

Radiology

Solid State Fluoroscopic X-Ray Imager

Radiology

Processor, Radiographic-Film, Automatic

Radiology

Test-Pattern, Radiographic

Radiology

Densitometer, Bone

Radiology

Image Management Software For Planning Of Otologic And Neurotologic Procedures

Radiology

Radiological Software Device To Predict Future Breast Cancer Risk

Radiology

Device, Beam Limiting, X-Ray, Diagnostic

Radiology

Prostate Immobilizer Rectal Balloon

Radiology

Device, Communications, Images, Ophthalmic

Radiology

System, X-Ray, Mammographic

Radiology

Chair, Pneumoencephalographic

Radiology

Phantom, Anthropomorphic, Radiographic

Radiology

Changer, Radiographic Film/Cassette

Radiology

System, Applicator, Radionuclide, Remote-Controlled

Radiology

Radiological Machine Learning Based Quantitative Imaging Software With Change Control Plan

Radiology

Needle, Isotope, Gold, Titanium, Platinum

Radiology

Shield, Gonadal

Radiology

Source, Teletherapy, Radionuclide

Radiology

System, Image Processing, Radiological

Radiology

Arthrogram Tray

Radiology

Tube Mount, X-Ray, Diagnostic

Radiology

Device, Digital Image Storage, Radiological

Radiology

Post Breast Biopsy Hemostatic Breast Compression Device

Radiology

Collimator, Low Voltage, Therapeutic X-Ray

Radiology

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance

Radiology

Source, Isotope, Sealed, Gold, Titanium, Platinum

Radiology

Table, Radiologic

Radiology

System, Applicator, Radionuclide, Manual

Radiology

Programmer, Changer, Film/Cassette, Radiographic

Radiology

Radiological Computer Assisted Detection/Diagnosis Software For Fracture

Radiology

Holder, Radiographic Cassette, Wall-Mounted

Radiology

Radiographic Contrast Tray

Radiology

System, X-Ray, Fluoroscopic, Image-Intensified

Radiology

Automated Radiological Image Processing Software

Radiology

System, Imaging, X-Ray, Electrostatic

Radiology

Coil, Magnetic Resonance, Specialty

Radiology

Device, Spot-Film

Radiology