Oncospace

K202284

Oncospace, Inc. · cleared 2021-03-12 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Oncospace is a software-only medical device that performs the same functions in the predicate, RT Elements, device. The software includes machine learning algorithms that are locked during use.”
Algorithmstatic machine learning models and statistical/database lookup methods
source quote (p.5)
“In the current software release, static machine learning models are used for prostate plan predictions, and statistical/database lookup methods are used for thoracic, pancreas, and head & neck plan predictions.”
Adaptive (vs locked)No
source quote (p.4)
“The software includes machine learning algorithms that are locked during use. In the current software release, static machine learning models are used for prostate plan predictions, and statistical/database lookup methods are used for thoracic, pancreas, and head & neck plan predictions.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“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

sample size not stated

endpoints: reduce the number of iterations necessary to achieve a clinically viable and deliverable radiation treatment plan

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
4
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K222803 (decision 2023-02-02) 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:K222803

  • 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/K202284