# K981410: Hammersmith Endocavitary Coils

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Jun 30, 1998 after 71 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- 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: 1 generation back to K930193 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K011683: Nurvo 9000 Endocavitary Coils (2001), 0 descendants of its own

## Indications for use
The Hammersmith Endocavitary Coils do not change the intended use of the Picker MR system with which they are used. Picker MR systems are intended for use as NMR devices that produce images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon NMR parameters (proton density, flow velocity, 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. The Hammersmith Endocavitary Coils are indicated for use in the following anatomic regions and with the designated nuclei: Anatomic Regions: The Anus or Prostate by insertion into the rectum, and the Cervix by insertion into the vagina Nuclei Excited: Hydrogen

Source page: https://510kreport.com/device/K981410
Methodology: https://510kreport.com/methodology