# K011683: Nurvo 9000 Endocavitary Coils

- Pathway: 510(k) (Traditional)
- Applicant: Usa Instruments, Inc.
- Decided: Dec 10, 2001 after 194 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K930193 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981410: Hammersmith Endocavitary Coils, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 2.
- K930193: Philips Endo-Cavitary Mri Coil, Philips Medical Systems, Inc. (1994) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K011683
Methodology: https://510kreport.com/methodology