510(k) · Cleared
ClearedNurvo 9000 Endocavitary Coils
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Instruments, Inc. · MOS Coil, Magnetic Resonance, Specialty
Cleared on Dec 10, 2001 as substantially equivalent to K981410 (Philips Medical Systems (Cleveland), Inc., 1998) and 1 other predicate after a 194-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Dec 10, 2001
- Review
- 194 days
- Class
- Class II
- Product code
- MOS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K930193 (1994). 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 MOS? 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 MOS device
- #1 K253738 3.0T Air 32CH Hnascore 15.2 · 16 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 |
|---|---|---|---|
| * | K981410 | Hammersmith Endocavitary CoilsSummary page 2…y insertion into the rectum, and the cervix by insertion into the vagina -Similar to the Hammersmith Endocavitary Coils manufactured by Marconi Medical Systems, Inc. (K981410) -Similar to the Philips Endocavitary MRI Coils manufactured by Philips Medical Systems, Inc. (K930193) Indications for Use Ide… | 1998 |
| * | K930193 | Philips Endo-Cavitary Mri CoilSummary page 2…ndocavitary Coils manufactured by Marconi Medical Systems, Inc. (K981410) -Similar to the Philips Endocavitary MRI Coils manufactured by Philips Medical Systems, Inc. (K930193) Indications for Use Identical to routine MRI imaging -Similar to the Hammersmith Endocavitary Coils manufactured by Marconi Me… | 1994 |
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 7 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All MOS devicesMOS Coil, Magnetic Resonance, Specialty: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MOS
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MOS
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MOS
13in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MOS
2in 2025
MAUDE reports naming product code MOS, 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 | 16 | 19 | 0 | 4 |
| 2008 | 19 | 33 | 2 | 2 |
| 2009 | 10 | 43 | 0 | 5 |
| 2010 | 16 | 78 | 1 | 13 |
| 2011 | 25 | 57 | 0 | 7 |
| 2012 | 15 | 49 | 1 | 12 |
| 2013 | 7 | 87 | 0 | 10 |
| 2014 | 12 | 60 | 0 | 4 |
| 2015 | 6 | 58 | 2 | 5 |
| 2016 | 11 | 42 | 0 | 7 |
| 2017 | 9 | 63 | 0 | 9 |
| 2018 | 10 | 30 | 0 | 7 |
| 2019 | 3 | 178 | 8 | 8 |
| 2020 | 5 | 51 | 1 | 2 |
| 2021 | 4 | 41 | 0 | 3 |
| 2022 | 11 | 79 | 0 | 5 |
| 2023 | 10 | 59 | 0 | 4 |
| 2024 | 10 | 39 | 13 | 8 |
| 2025 | 3 | 59 | 0 | 2 |
| 2026 | 10 | 45 | 0 | — |
What is it indicated for?
The Nuvo 9000 Endocavitary Coils are three receive only RF Coils designed to provide diagnostic images of the anus, prostate and cervix in Magnetic Resonance Imaging. The Nuvo 9000 Endocavitary Coils are single-use disposable devices that are delivered and packaged in a sterile state. The Nuvo 9000 Endocavitary Coils are designed for use with Marconi Medical Systems and GE Medical Systems MRI Scanners. Anatomic Regions: Anus, Prostate, and Cervix Nuclei…
Read the full statement (161 words)
The Nuvo 9000 Endocavitary Coils are three receive only RF Coils designed to provide diagnostic images of the anus, prostate and cervix in Magnetic Resonance Imaging. The Nuvo 9000 Endocavitary Coils are single-use disposable devices that are delivered and packaged in a sterile state. The Nuvo 9000 Endocavitary Coils are designed for use with Marconi Medical Systems and GE Medical Systems MRI Scanners.
Anatomic Regions: Anus, Prostate, and Cervix
Nuclei Excited: Hydrogen
The indications for use are the same as for standard imaging:
The Marconi MRI Scanners and GE MRI Scanners are indicated for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.
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/K011683 · printed Nov 4, 2026
Cite this page
510(k) Report. “K011683: Nurvo 9000 Endocavitary Coils.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K011683
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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