# K904908: Stereotactic Irradiation System

- Pathway: 510(k) (Traditional)
- Applicant: Northwest Medical Physics Center
- Decided: Jun 6, 1991 after 218 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 18, 2008 · Not classified · Z-2137-2008: A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
- Apr 7, 2006 · Not classified · Z-1146-2007: This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table po
- Jan 2, 2006 · Not classified · Z-1145-2007: Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
- May 31, 2005 · Not classified · Z-1147-2007: When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window 
- Apr 28, 2005 · Not classified · Z-1152-2007: When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
- Apr 11, 2005 · Not classified · Z-1153-2007: When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
- Dec 30, 2004 · Not classified · Z-1154-2007: When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
- Nov 30, 2004 · Not classified · Z-1155-2007: When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously d

Source page: https://510kreport.com/device/K904908
Methodology: https://510kreport.com/methodology