QT Scanner 2000 Model A
K253898QT Imaging Holdings, Inc. · cleared 2026-03-04 · product code IYO · Radiology
Premarket evidence — what FDA accepted
source quote (p.6)
“The subject QT Scanner 2000 Model A (“QT Scanner”) is an automated, software-controlled ultrasound imaging system which performs a standardized scan of the whole breast without the use of ionizing radiation, compression, or contrast injection; and generates both reflection-mode and transmission-mode breast images.”
Validation studies (2)
Bench
sample size not stated
standards: ISO 10993-1:2009/(R)2013, IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 60601-2-37:2015, NEMA UD 2-2004 (R2009), IEC 60601-1-6:2013, IEC 62366:2014, IEC 62304:2015
Reader study (MRMC)
sample size not stated
endpoints: image quality
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
- recall_reason_pattern
Software/algorithm-related recall in product code IYO (Civco Medical Instruments Co. Inc., initiated 2026-03-02): "There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98513
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).