# K013218: Fuji Speed Suite, Fuji Speed Sute Phase II

- Pathway: 510(k) (Abbreviated)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Dec 20, 2001 after 85 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K803130 (1981). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971452: Multix Top/Pro Radiographic X-Ray Table, Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K001201: Multix Compact K and Multix L Radiographic X-Ray Systems, Siemens Medical Solutions USA, Inc. (2000) Summary page 1.
- K993861: Fuji Computed Radiography Dual Side Reading, Both Side Reading, FCR 5501D Dual Side Reader, Fujifilm Medical System U.S.A., Inc. (2000) Summary page 1.
- K972256: FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks), Fujifilm Medical System U.S.A., Inc. (1997) Summary page 1.

## Most influential descendants
- K091631: Accessnet, Accessmed, Accessrad, Medview (2010), 0 descendants of its own

## Recalls of this device
- May 5, 2004 · Not classified · Z-0993-04: Software: Incorrect measurement of objects within a CR image

## Indications for use
The indications for use for the FUJI SPEED SUITE is the same as the predicate device: radiographic exposures of the entire body specifically the skull, spinal column, chest, and abdomen, as well as extremities, the identification, capture, digitization, and processing of diagnostic x-ray images, and associating patient and exam identification with the images.

Source page: https://510kreport.com/device/K013218
Methodology: https://510kreport.com/methodology