510(k) · Cleared
ClearedStrata, Model V.O.95
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rosses Medical Systems · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Dec 11, 1998 after a 213-day review. The FDA summary names its predicate without a number.
- Decided
- Dec 11, 1998
- Review
- 213 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Prowess 2000 (SSGI, Inc.) Named without a submission number | |
| * | — | Therpac PLUS B3D TUI (Multimedia Medical Systems, Inc.) Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist. The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for…
Read the full statement (109 words)
The proposed Strata system must be used by a qualified clinical staff member (generally a Medical Physicist or Dosimetrist), the results should then be approved by a licensed Radiation Oncologist.
The proposed Strata device is intended to assist the clinician in determining optimal placement of Low Dose Rate radioisotopes about a lesion or tumor (benign or malignant) seated in human tissue. The information gathered in this planning system is used for localization, visualization of regional interest, calculating dose of implanted radioisotopes, and finally out putting data in hardcopy form (printer/plotter).
Strata is not intended to prescribe dose, invade the patient or control hardware which can directly harm the patient.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981678: Strata, Model V.O.95.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981678
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026