510(k) · Cleared
ClearedRadvision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Acoustic Medsystems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 16, 2013 as substantially equivalent to K982696 (Burdette Medical Systems, Inc., 1999) and 2 other predicates after a 60-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Jul 16, 2013
- Review
- 60 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K850571 (1985). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK850571 I-125 Implant GunMick Radio-Nuclear Instruments, Inc. · 1985
- 2 generations backK972672 Brachystepper Stepping Unit, Brachystepper Needle Guide Template…Barzell-Whitmore Maroon Bells, Inc. · 1997
- 1 generation backK982696 InterplantBurdette Medical Systems, Inc. · 1999 · Recalled
- This deviceK131428 RadvisionAcoustic Medsystems, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850571 | I-125 Implant Gun | Mick Radio-Nuclear Instruments, Inc. | 1985 | — |
| −2 | K972672 | Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand… | Barzell-Whitmore Maroon Bells, Inc. | 1997 | — |
| −1 | K982696 | Interplant | Burdette Medical Systems, Inc. | 1999 | 1 |
| 0 (this device) | K131428 | Radvision | Acoustic Medsystems, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K982696 | InterplantSummary page 1…(4) Legally Marketed Predicate Devices: Burdette Medical Systems, Inc. Interplant, 510(k) number K982696 dated 1April 1999 Varian Medical Systems BrachyVision 6.0,… | 1999 |
| * | K992762 | Brachyvision 6.0Summary page 1…510(k) number K982696 dated 1April 1999 Varian Medical Systems BrachyVision 6.0, 51 0(k) number K992762 dated 03 March 2000 Varian Medical Systems VaniSeed 7.1, 51 0… | 2000 |
| * | K030534 | Variseed 7.1Summary page 1…51 0(k) number K992762 dated 03 March 2000 Varian Medical Systems VaniSeed 7.1, 51 0(k) number K(030534 dated 21 May 2003 Telephone: 21 7-239-0900 Facsimile: 21… | 2003 |
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.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 12.3 years on median.
- 4 of the 12 ancestors have a recall of any class.
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. 2013, this device’s year, is highlighted.
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 intended use of Acoustic MedSystems, Inc. RadVision Dose Planning and Treatment Systems is to provide patient-specific planning, imaging, and implants or applicator device alignment for treating cancer using radioactive seed implants or HOR afterloader devices. In addition to planning and treatment, PadVision also allows volume and dose calculations, 2D and 3D anatomy arnd dose visualizations, and post treatment seed localization.
PadVision is a general purpose brachytherapy planning system used for prospective and confirmation dose calculations for patients undergoing a course of brachytherapy using either temporary or permanent implants ot various radioisotopes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131428: Radvision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131428
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026