MRI Planner

K211841

Spectronic Medical AB · cleared 2022-08-25 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“MRI Planner is a software-only medical device intended for use by trained radiation oncologists, dosimetrists and physicists to process images from MRI systems to”
Algorithmpre-trained machine learning models
source quote (p.5)
“MRI Planner utilizes pre-trained machine learning models to perform both the conversion to synthetic CT and the automated structure contouring.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

n=58 patients · 6 site(s)

endpoints: dosimetric equivalence; mean doses to target and non-target volumes; gamma evaluation

standards: ISO 14971 Second edition 2007-03-01 Medical devices – Application of risk management to medical devices, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes, IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety

Bench

n=75 patients · 4 site(s)

endpoints: dosimetric equivalence; mean doses to target and non-target volumes; gamma evaluation

standards: ISO 14971 Second edition 2007-03-01 Medical devices – Application of risk management to medical devices, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes, IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety

Bench

n=51 patients · 5 site(s)

endpoints: Dice score (DSC); 95% Hausdorff distance (HD)

standards: ISO 14971 Second edition 2007-03-01 Medical devices – Application of risk management to medical devices, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes, IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices, IEC 82304-1 Edition 1.0 2016-10 Health software – Part 1: General requirements for product safety

Reported performance (3 observations)

diceas written: “average DSC (bladder)”0.95CI ± 0.03
source quote (p.7)
“The average DSC was found to be 0.95 ± 0.03, 0.90 ± 0.04 and 0.96 ± 0.01 for bladder, colon and femoral head delineations, respectively.”
diceas written: “average DSC (colon)”0.9CI ± 0.04
source quote (p.7)
“The average DSC was found to be 0.95 ± 0.03, 0.90 ± 0.04 and 0.96 ± 0.01 for bladder, colon and femoral head delineations, respectively.”
diceas written: “average DSC (femoral head)”0.96CI ± 0.01
source quote (p.7)
“The average DSC was found to be 0.95 ± 0.03, 0.90 ± 0.04 and 0.96 ± 0.01 for bladder, colon and femoral head delineations, respectively.”

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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97049

  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97309

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K211841