Oncospace

K222803

Oncospace, Inc. · cleared 2023-02-02 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The Oncospace subject device is a software-only medical device that performs the same functions in the Oncospace predicate device. The software includes locked machine learning algorithms.”
Algorithmmachine learning algorithms
source quote (p.4)
“The software includes locked machine learning algorithms. The machine-learning algorithm has been generalized to allow training, modeling, and testing of dosimetric predictions for treatment target/organ-at-risk geometries and a head and neck model has been developed and added to the subject device.”
Adaptive (vs locked)No
source quote (p.6)
“The predicate device and subject device algorithms, and any future algorithm updates, are locked prior to clinical use.”
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“The verifications tests met all system requirements and acceptance criteria which address clinical, standard user interface, and cybersecurity requirements for the Oncospace device.”

Validation studies (1)

Retrospective clinical

n=32 cases

endpoints: non-inferiority of mean organ-at-risk (OAR) dose sparing; target coverage; number of plan optimization iterations

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

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

    The FDA AI/ML device list shows a newer 510(k) K242748 (decision 2025-04-11) from Oncospace, Inc. for a matching device line ("Oncospace") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K242748

  • 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/K222803