Oncospace
K222803Oncospace, Inc. · cleared 2023-02-02 · product code MUJ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The Oncospace software supports radiation oncologists and medical dosimetrists during radiotherapy treatment planning. The software includes locked machine learning algorithms.”
source quote (p.4)
“The Oncospace software includes locked machine learning algorithms.”
source quote (p.6)
“Note: The predicate device and subject device algorithms, and any future algorithm updates, are locked prior to clinical use.”
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 other
endpoints: non-inferiority of mean organ-at-risk (OAR) dose sparing; target coverage; number of plan optimization iterations required
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
- 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). 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).