# K093984: Pica Whole Body Mri System Model TMS-Mri-3500WB-01

- Pathway: 510(k) (Special)
- Applicant: Time Medical Limited
- Decided: Mar 24, 2010 after 90 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: 2 generations back to K073457 (2008). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091580: Pica Whole Body Mri System, Time Medical Limited (2009) Summary page 1.

## Most influential descendants
- K110942: Pica Whole-Body Mri System (2011), 0 descendants of its own

## Indications for use
Pica Whole Body MRI System, TMS-MRI-3500WB-01 is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, and that display the internal structure and/or function of the head, body or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. It may be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.

Source page: https://510kreport.com/device/K093984
Methodology: https://510kreport.com/methodology