510(k) · Cleared
ClearedNomos Motorized Crane II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nomos Corp. · JAI Couch, Radiation Therapy, Powered
Cleared on Dec 7, 2001 as substantially equivalent to K991966 (Nomos Corp., 1999) after an 88-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Dec 7, 2001
- Review
- 88 days
- Class
- Class II
- Product code
- JAI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K941927 (1995). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 JAI? 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 JAI device
- #1 K231612 Eve Patient Positioner Systemscore 7.9 · 3 generations · no Class I recall
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 |
|---|---|---|---|
| * | K991966 | The Nomos Chane IISummary page 1…a Director of Quality NOMOS Corporation 2591 Wexford Bayne Road Sewickley, PA 15143 Phone: 724-934-8242 FAX: 724-934-5488 B. Name of predicate device: NOMOS CRANE Il (K991966) C. Classification: Class Il D. Performance Standards: None established E. Intended Use and Device Description: Intended Use:… | 1999 |
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 6 years and passes through 1 company; a new generation was cleared every 4.6 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All JAI devicesJAI Couch, Radiation Therapy, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JAI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JAI
61in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAI
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAI
1in 2024
MAUDE reports naming product code JAI, 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 | 2 | — | 1 | 4 |
| 2008 | 0 | — | 2 | 2 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 2 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 4 | 61 | 0 | 2 |
| 2013 | 1 | — | 2 | 5 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 2 |
| 2017 | 1 | — | 1 | 3 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 2 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NOMOS Motorized CRANE Il is intended to be used as an accessory to powered radiation therapy patient support tables. The NOMOS Motorized CRANE Il verifies and describes, via a set of Z and X coordinates, the set-up of the table/patient prior to treatment.
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/K013036 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013036: Nomos Motorized Crane II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013036
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026