Profile: Hologic Inc develops, manufactures and supplies premium diagnostic & medical imaging systems dedicated to serve the healthcare needs of women. We produce digital imaging technology for general radiography and mammography applications. Our Selenia uses selenium based direct capture technology that eliminates light diffusion completely for perfect clarity and exquisite image quality. We offer products such as digital mammography, analog mammography, breast biopsy, CAD and film digitizers, bone densitometry, fluoroscan mini C-arm, surgical products, diagnostic cytology, extremity MRI, general radiography, biomed training & hologic iStore. We offer customers an opportunity to enroll their bio-medical engineers into one or more of our world-class service training programs. Our training programs provide bio-medical engineers with the knowledge and confidence to be successful when servicing our products. Our training programs optimize a students learning experience by providing a quality balance of lecture, lab and hands-on experience with the product.

The company was founded in 1985. NASDAQ:HOLX (SEC Filings)

FDA Registration Number: 1220984

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• Adhesive Bandages (FDA Code: KGX / 880.5240) A medical adhesive tape or adhesive bandage is a device intended for medical purposes that consists of a strip of fabric material or plastic, coated on one side with an adhesive, and may include a pad of surgical dressing without a disinfectant. The device is used to cover and protect wounds, to hold together the skin edges of a wound, to support an injured part of the body, or to secure objects to the skin.

• Amniotic Fluid Sampler (FDA Code: HIO / 884.1550) The amniotic fluid sampler (amniocentesis tray) is a collection of devices used to aspirate amniotic fluid from the amniotic sac via a transabdominal approach. Components of the amniocentesis tray include a disposable 3 inch 20 gauge needle with stylet and a 30 cc. syringe, as well as the various sample collection accessories, such as vials, specimen containers, medium, drapes, etc. The device is used at 16-18 weeks gestation for antepartum diagnosis of certain congenital abnormalities or anytime after 24 weeks gestation when used to assess fetal maturity.

• Analog Mammography

• Analogue Fluoroscopy System

• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020) Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:

• Analytical X-Ray Equipment

• Automated Cervical Cytology Slide Reader (FDA Code: MNM)

• Automated Cytology Slide Processor (FDA Code: MKQ)

• Basic Fluoroscopy System

• Biopsy Instruments (FDA Code: KNW / 876.1075) A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Bone Densitometer (FDA Code: KGI / 892.1170) A bone densitometer is a device intended for medical purposes to measure bone density and mineral content by x-ray or gamma ray transmission measurements through the bone and adjacent tissues. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Bone Densitometry

• Bone Sonometer (FDA Code: MUA / 892.1180)

• C-Arm Portable Fluoroscopy

• C-arms

• CAD (Computer-aided Detection) Kits

• Clinical Sample Concentrator (FDA Code: JJH / 862.2310) A clinical sample concentrator is a device intended to concentrate (by dialysis, evaporation, etc.) serum, urine, cerebrospinal fluid, and other body fluids before the fluids are analyzed.

• Computer-Aided Detection Lung Computed Tomography System (FDA Code: OEB / 892.2050) A picture archiving and communications system is a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification.

• Contraceptive Tubal Occlusion Device (FDA Code: KNH / 884.5380) A contraceptive tubal occlusion device (TOD) and introducer is a device designed to close a fallopian tube with a mechanical structure, e.g., a band or clip on the outside of the fallopian tube or a plug or valve on the inside. The devices are used to prevent pregnancy.

• Contract Manufacturers

• Cytocentrifuge (FDA Code: IFB / 864.3300) A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.

• Cytological Preservative (FDA Code: LEA / 864.4010)

• Densitometers

• Diagnostic Products

• Diagnostic X-Ray Tube Mount (FDA Code: IYB / 892.1770) A diagnostic x-ray tube mount is a device intended to support and to position the diagnostic x-ray tube housing assembly for a medical radiographic procedure.

• Digital Mammography Systems

• Digital Radiographic Mobile X-Ray System

• Digital X-Ray Equipment

• Drug Metabolizing Enzyme Genotyping Systems (FDA Code: NTI / 862.3360)

• Endometrial Ablation System

• Endometrial Thermal Ablation Device (FDA Code: MNB)

• External Breast Expander (FDA Code: MWZ)

• Fetal Fibronectin Enzyme Immunoassay (FDA Code: LKV)

• Film Digitizers

• Fluoroscopic Imaging Systems

• Fluoroscopy Systems

• Gene Mutation Detection, Cystic Fibrosis Transmembrane Conductance Regulator System (FDA Code: NUA / 866.5900)

• General Diagnostic Supplies

• General Health Supplies

• General Medical Supplies

• General Purpose Reagent (FDA Code: LDT)

• General Surgery Supplies

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Human Papillomavirus DNA Detection Kit (FDA Code: MAQ)

• Hysteroscope Accessories (FDA Code: NWW / 884.1690) A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

• Image-Intensified Fluoroscopic X-Ray System (FDA Code: JAA / 892.1650) An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

• Implantable Radiographic Marker (FDA Code: NEU / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Labeled Medical Laboratory Equipment (FDA Code: LXG / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Magnetic Resonance Imaging