ThinPrep Imaging System
PMA P020002
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA PMAAPCB | NumberP020002 | Date6 Jun 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Full name
- Thinprep (R) Imaging System
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- PMA number
- FDA product code
- MNM
- Device class
- Class III
- Advisory committee
- Pathology
- FDA decision
- APCB
Overview
AI-generated summary, 18 Sep 2026
The ThinPrep Imaging System is an automated reader for cervical cytology slides, classified as a Class III medical device. It assists in primary cervical cancer screening by analyzing ThinPrep Pap test slides for atypical cells, cervical neoplasia, and precursor lesions, adhering to the 2001 Bethesda System terminology for reporting cytological criteria.
This system is designed for use in pathology laboratories, where it processes ThinPrep slides to detect cellular abnormalities. Supplied as a reusable device, it requires no specific sterility measures beyond standard laboratory protocols. The system operates independently of MRI safety considerations and is authorized under FDA PMA (P020002). No additional regulatory status beyond the stated PMA approval is implied.
Other devices from Hologic, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the ThinPrep Imaging System in a pathology lab setting?
The ThinPrep Imaging System is designed to assist in primary cervical cancer screening by automatically analyzing ThinPrep Pap test slides. It detects atypical cells, cervical neoplasia, and precursor lesions—such as low-grade and high-grade squamous intraepithelial lesions—using the 2001 Bethesda System terminology for reporting cytological findings.
Is the ThinPrep Imaging System intended for single-use or reusable applications in a lab?
The ThinPrep Imaging System is a reusable device, meaning it is built for repeated use in pathology laboratories. Since it is not a consumable or disposable item, standard laboratory cleaning and maintenance protocols apply, and no additional sterility measures beyond routine lab practices are required.
How is the ThinPrep Imaging System regulated, and what does its FDA authorization cover?
The ThinPrep Imaging System holds FDA **PMA (Premarket Approval) authorization** under the PMA number **P020002**, which specifically authorizes its use for assisting in primary cervical cancer screening of ThinPrep Pap test slides. This approval includes detection of atypical cells, cervical neoplasia, and precursor lesions as defined by the 2001 Bethesda System.
Does the ThinPrep Imaging System require any special handling or storage conditions?
As a reusable device, the ThinPrep Imaging System does not have unique sterility or storage requirements beyond standard laboratory protocols. It is designed for use in pathology labs, where typical environmental controls (e.g., temperature, humidity) and maintenance practices should be followed to ensure optimal performance.