Photonova Spectra, Photonova Spectra Select

K253520

Ge Medical Systems, LLC · cleared 2026-03-20 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.7)

“Photonova Spectra also includes a next generation deep learning reconstruction commercially known as TrueFidelity DL for PCCT using a multi-layer convolution neural network (CNN) that is designed to produce low noise images.”

Algorithmmulti-layer convolution neural network (CNN)

source quote (p.7)

“Photonova Spectra also includes a next generation deep learning reconstruction commercially known as TrueFidelity DL for PCCT using a multi-layer convolution neural network (CNN) that is designed to produce low noise images.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: CT number; water accuracy; mean CT number over a range of spectral tasks; in-plane resolution; cross-plane resolution; noise texture; Low contrast detectability (LCD)

standards: AAMI/ANSI ES 60601-1, IEC60601-1 Ed. 3.2, NEMA XR 25, NEMA XR 28, IEC 61223-3-5 ed 2

Reader study (MRMC)

sample size not stated

endpoints: diagnostic utility; diagnostic interpretability; overall performance; preservation of anatomical information

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

recalls in product code, 24mo

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98738
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98588
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:97699
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips Medical Systems Nederland B.V. Veenpluis, initiated 2025-02-28): "Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement." Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:96423
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
…and 3 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).