NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
K243523Siemens Medical Solutions USA, Inc. · cleared 2025-02-12 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*.”
source quote (p.40)
“Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.”
Validation studies (1)
Bench
sample size not stated
endpoints: verify and validate the functionality of the subject device modifications; assess the image quality of Flex 4D Spiral; assess the fraction (percentage) of ranges calculated by the FAST Planning algorithm that are correct and can be applied without change
standards: NEMA PS 3.1 - 3.20 2022d, NEMA XR 25-2019, NEMA XR 28-2018, IEC 61223-3-5 Edition 2.0 2019-09, IEC 61223-2-6 Second Edition 2006-11, IEC 60601-1-3 Edition 2.1 2013-04, IEC 60601-2-44 Edition 3.2: 2016, ANSI AAMI ISO 14971: 2019, ISO 14971 Third Edition 2019-12, ANSI AAMI IEC 62304:2006/A1:2016, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021], ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021], IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION, ANSI AAMI IEC 62366-1:2015+AMD1:2020 (Consolidated Text), IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION, IEC 60825-1 Edition 2.0 2007-03, IEC 60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION, IEC 60601-2-28 Edition 3.0 2017-06, IEC 62563-1 Edition 1.2 2021-07, IEC 60601-1:2005+A1:2012+A2:2020, IEC/ISO 17050-1, IEC/ISO 17050-2
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 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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98206
- 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 is another firm in the same product code.
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 is another firm in the same product code.
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 is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
- …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).