Precise Position

K203514

Philips Healthcare (Suzhou) Co., Ltd. · cleared 2021-06-17 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.5)

“Precise Position including a camera with both color and depth function is installed in the ceiling of the scan room, in such a way to cover the entire patient on the patient table. The camera control and image data transmit via the high speed fiber and copper hybrid USB cable. The power supply of the camera is from the gantry. Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy.”

AlgorithmAI algorithm (Convolution Neural Network)

source quote (p.5)

“Precise position adopts the AI algorithm (Convolution Neural Network) to detect the joints of the patient body, and then identify surview start/end position and patient orientation. The algorithm can also support detect center of patient anatomy.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=80 cases

endpoints: To calculate the time saved per surview planning with and without Precise Position.; To calculate the accuracy of vertical (iso)center positioning and Surview (horizontal) start /end position with and without Precise Position; Intra operator consistency in positioning the patient and surview scan range

standards: AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R) 2012 and A2:2010/(R) 2012, IEC 60601-1:2012, MOD, IEC 60601-1-2:2014, ISO 14971 Medical devices – Application of risk management to medical devices., IEC 62304:2015, Medical device software -- Software life cycle processes

Reported performance (1 observation)

accuracyas written: “vertical position accuracy increased”50

source quote (p.9)

“results shown that with "Precise Position" the vertical position accuracy is increased up to 50%.”

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 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 (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 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).