510(k) · Cleared
ClearedPeregrine Radiation Therapy Dose Calculation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nomos Corp. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Sep 5, 2000 as substantially equivalent to K926008 (Adac Laboratories, 1994) after a 309-day review. Its family tree reaches back 1 generation to 1994. 14 later devices descend from it.
- Decided
- Sep 5, 2000
- Review
- 309 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926008 (1994). 14 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK926008 Pinnacle 3Adac Laboratories · 1994
- This deviceK993675 Peregrine Radiation Therapy Dose Calculation SystemNomos Corp. · 2000
- Descendant · cites it directly · 13 of its ownK071938 Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 12 of its ownK091179 Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 8 of its ownK110730 Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 7 of its ownK132971 MonacoImpac Medical Systems, Inc. · 2013 · Recalled
- Descendant · 5 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K071938Monaco RTP SystemComputerized Medical Systems, Inc. · 2007 · cites it directly13descendants
- K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 2009 · 2 generations on12descendants
- K110730Monaco RTP SystemComputerized Medical Systems, Inc. · 2011 · 3 generations on8descendants
- K132971MonacoImpac Medical Systems, Inc. · 2013 · 4 generations on7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926008 | Pinnacle 3 | Adac Laboratories | 1994 | — |
| 0 (this device) | K993675 | Peregrine Radiation Therapy Dose Calculation System | Nomos Corp. | 2000 | — |
| +1 | K071938 | Monaco RTP System | Computerized Medical Systems, Inc. | 2007 | 5 |
| +2 | K091179 | Monaco RTP System, Vmat Option | Computerized Medical Systems, Inc. | 2009 | 5 |
| +3 | K110730 | Monaco RTP System | Computerized Medical Systems, Inc. | 2011 | 6 |
| +4 | K132971 | Monaco | Impac Medical Systems, Inc. | 2013 | 4 |
| +5 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K926008 | Pinnacle 3Summary page 1…ification name: Accelerator, Linear, Medical, Accessory 90 IYE [21 CFR 892.5050] (a) (3) Predicate device: ADAC Laboratories Pinnacle® 3D Treatment Planning Throughput K926008 (a) (4) Device description: The PEREGRINE Radiation Therapy Dose Calculation System is a 3-D Monte Catlo radiation transport sy… | 1994 |
What descends from it? (14)
See all 141 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071938 | Monaco RTP System | 2007 | 13 |
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?
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 PEREGRINE™ Radiation Therapy Dose Calculation System is used in conjunction with a radiation treatment planning system to provide the dose distribution for radiation therapy treatments employing radiation sou:ces and associated beam modifiers for clinical review and judgement prior to treating the patient. The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, or dosimetrist.
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/K993675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993675: Peregrine Radiation Therapy Dose Calculation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993675
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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