# K982952: Imfast

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 5, 1999 after 193 days
- Product code: LHN (System, Radiation Therapy, Charged-Particle, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K953894 (1995). 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)
- K961902: Siemens Beam Shaper, Siemens Medical Solutions USA, Inc. (1996) Summary page 1.

## Indications for use
The IMFAST product is intended to calculate a sequence of multi-leaf collimator (MLC) segments. These resulting segments are then written to a file, allowing the V&R system or the RTP system to pick it up for further processing. In the case of SIEMENS' LANTIS and PRIMEVIEW, the file can be imported and the segments can be grouped into intensity modulation groups. The treatment can then be delivered in sequence using SIMTEC and an MLC, thus providing the patient with automated, computer-controlled intensity modulation radiotherapy (IMRT).

Source page: https://510kreport.com/device/K982952
Methodology: https://510kreport.com/methodology