CLEARREAD +CONFIRM
K123526RIVERAIN TECHNOLOGIES · cleared 2012-12-27 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.1)
“ClearRead +Confirm is a dedicated post-processing application that generates an enhanced, secondary digital radiographic image of the chest to facilitate confirmation of line/tubes.”
source quote (p.2)
“ClearRead +Confirm uses the same bone suppression mechanism as the Riverain ClearRead Bone Suppression predicate device, with enhancements to improve the visibility of lines and tubes.”
Validation studies (2)
Bench
sample size not stated
endpoints: verify that the design output met the design input requirements
Reader study (MRMC)
sample size not stated
endpoints: reduction in time required by the radiologists to localize the tips of tubes, lines, and electrical cardiac wires (TLW); radiologists' accuracy in localizing the TLW
Reported performance (1 observation)
source quote (p.3)
“The difference from true locations in ClearRead Confirm reads and unaided reads were not found to be statistically significant.”
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K161201 (decision 2016-09-09) from RIVERAIN TECHNOLOGIES, LLC for a matching device line ("ClearRead CT") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K161201
- adverse_event_inflection
MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.
first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:99042
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98520
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98428
- recall_reason_pattern
Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98137
- …and 21 more.
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).