PMA · Approved
ApprovedImagechecker CT Cad Software System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · NRR (no longer in FDA’s product-code list)
Approved on Jul 8, 2004 through premarket approval, which rests on the device’s own clinical evidence after a 449-day review.
- Decided
- Jul 8, 2004
- Review
- 449 days
- Class
- Class III
- Product code
- NRR
- Recalls
- None
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NRR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
https://510kreport.com/device/P030012 · printed Nov 4, 2026
Cite this page
510(k) Report. “P030012: Imagechecker CT Cad Software System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/P030012
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026