Radiography 7300 C

K233662

Philips Medical Systems DMC GmbH · cleared 2024-06-13 · product code KPR · Radiology

Premarket evidence — what FDA accepted

In parse queue — the device is on the FDA AI/ML list but its 510(k) summary hasn't been extracted yet (or has no public PDF). This is our gap, not a device finding.

Predicate network

Postmarket — what happened after clearance

13
recalls in product code, 24mo
42
MAUDE reports in code, 12mo
+14%
vs code's own 3-yr baseline
0
drift signals on this device

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).

RIGOR™ Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: radar.healthai.com/precedent/device/K233662