ThinPrep Imaging System Imaging Station
ThinPrep Imaging System Imaging Station (71050-001) is a medical device (FDA Class III; FDA product code MNM, Reader, Cervical Cytology Slide, Automated) made by Hologic, approved under FDA PMA P020002 on 6 Jun 2003 and listed in FDA GUDID since 2 Sep 2014 (UDI-DI 15420045500938), active as of 23 Oct 2026.
Active
PMA
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number15420045500938 | Date2 Sep 2014 | StatusListed |
| United States | FDA PMAAPCB | NumberP020002 | Date6 Jun 2003 | StatusActive |
Official records
- AccessGUDID record 15420045500938
- FDA PMA database P020002
Across registries
- FDA PMA P020002 decided 6 Jun 2003 Active
- FDA GUDID UDI-DI 15420045500938 listed 2 Sep 2014 Listed
Timeline
- Approved FDA PMA P020002
- Listed FDA GUDID 15420045500938
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA PMA Active
Specification
- Trade name
- ThinPrep Imaging System
- Generic name
- Laboratory instrument/analyser application software IVD
- Model / Ref / Catalog
- ThinPrep Imaging System Imaging Station, 71050-001
- Primary DI / UDI-DI
- 15420045500938
- PMA number
- FDA product code
- MNM
- GMDN term
- Laboratory instrument/analyser application software IVD
- Device class
- Class III
- GUDID distribution status
- In Commercial Distribution
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