Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006330030

FEI Number

3006330030

Entity Name

Hologic, Inc.

City/State/Country

Marlborough, MA, US

Establishment Address

445 Simarano Drive, Marlborough, MA 01752, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

HOLOGIC, INC. (Owner Number: 9007676)

Owner / Operator Contact Address

250 Campus Drive, --, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P920048

All Registered Proprietary Names

NovaSure RF Controller NovaSure Device (Handpiece) NovaSure EndometrialAblation System ATEC Console Tissue Filter Eviva ATEC Needle Guides Introducer Localization Set (ILS) ATEC Adapters ThinPrep 5000 Processor ThinPrep Gynecological Slides ThinPrep Gynecological Filters ThinPrep 2000 Slide Processor ThinPrep Gynecological Preservative (PreservCyt) ThinPrep® CERV(TM) PreservCyt® Solution ThinPrep® CERV(TM) Gynecological Filters ThinPrep Genesis Processor Cellient ThinPrep Slides ThinPrep Arcless Slides SecurView DX PreservCyt and CytoLyt Acessa ProVu System Fluent ThinPrep Imaging System Stain MyoSure Reach Genius Digital Diagnostics System with the Genius Cervical AI algorithm ThinPrep filters Fluent Pro Fluid Management System ThinPrep Imaging System ThnPrep Integrated Imager Review Scope Manual + ThinPrep Processor TLiIQ Fetal Fibronectin Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MNB	Device, Thermal Ablation, Endometrial	Unknown	Class 3	N/A	2008-04-09
KNW	Instrument, Biopsy	Gastroenterology, Urology	Class 2	876.1075	2003-01-16
MNM	Reader, Cervical Cytology Slide, Automated	Unknown	Class 3	N/A	2008-01-21
MKQ	Processor, Cervical Cytology Slide, Automated	Unknown	Class 3	N/A	2008-01-21
IDT	Apparatus, Melting Point, Paraffin	Pathology	Class 1	864.3010	2008-05-23
KEW	Slides, Microscope	Pathology	Class 1	864.3010	2008-04-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2011-11-08
MKQ	Processor, Cervical Cytology Slide, Automated	Unknown	Class 3	N/A	2020-12-15
LEA	Preservative, Cytological	Pathology	Class 1	864.4010	2008-04-17
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2021-11-12
HFG	Coagulator, Laparoscopic, Unipolar (And Accessories)	Obstetrics/Gynecology	Class 2	884.4160	2021-11-12
OEW	Tracking, Soft Tissue, Intraoperative	Neurology	Class 2	882.4560	2021-11-12
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2021-11-12
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2018-08-03
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2018-08-03
MNM	Reader, Cervical Cytology Slide, Automated	Unknown	Class 3	N/A	2017-01-04
HZJ	Stain, Papanicolau	Hematology	Class 1	864.1850	2008-04-17
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2015-11-16
QYV	Digital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm	Pathology	Class 2	864.3900	2024-02-20
KET	Filters, Cell Collection, Tissue Processing	Pathology	Class 1	864.3010	2008-04-17
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-07-26
HIG	Insufflator, Hysteroscopic	Obstetrics/Gynecology	Class 2	884.1700	2024-07-26
MNM	Reader, Cervical Cytology Slide, Automated	Unknown	Class 3	N/A	2008-01-21
IFB	Cytocentrifuge	Pathology	Class 1	864.3300	2008-04-11
LKV	Enzyme Immunoassay, Fetal Fibronectin	Unknown	Class 3	N/A	2008-01-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013649990	HEALTH BEACONS, INC.	Marlborough, MA, US
3012644426	ENDOMAGNETICS LTD	Cambridge Cambridgeshire, GB
3005875675	GYNESONICS, INC.	REDWOOD CITY, CA, US
3010377594	BOLDER SURGICAL, LLC	LOUISVILLE, CO, US
3014090621	SOMATEX Medical Technologies GmbH	Blankenfelde-Mahlow Brandenburg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K172344	Medax Srl Unipersonale	Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)	2017-11-13
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2024	Bard Peripheral Vascular Inc	2	Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016
Z-0028-2013	Remington Medical Inc.	2	Automatic Cutting Needles, Soft Tissue Biopsy Needle, NAC-1820M, Sterile, Remington Medical, Inc., 5830 Meadowridge Court, Alpharetta, GA 30005. Prostate Biopsy Needles shall be single use only and are to be used by a Urologist in a healthcare setting to obtain needle biopsies of the prostate. The needles are compatible with the Bard Magnum biopsy instrument. The needles have an echogenic tip for accurate placement under ultrasound guidance and centimeter markings along the cannula to facilitate depth placement.
Z-0042-2014	Atossa Genetics, Inc.	2	Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Z-0044-2018	Bard Peripheral Vascular Inc	2	BARD MAX-CORE Disposable Core Biopsy Instrument, Product Codes - MC1410, 14 g x 10 cm; MC1616, 16 g x 16 cm; MC1816, 18 g x 16 cm; MC1820, 18 g x 20 cm; MC1825, 18 g x 25 cm. The core needle biopsy device is intended for use in obtaining biopsies from soft tissues.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006330030. Last updated year: 2026. Please use registration number 3006330030 when referencing this establishment in official correspondence.