# K991336: Bodyloc Whole Body Stereotactic Localizer System for Radiotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Medical Instrumentation & Diagnostics Corp.(Midco)
- Decided: Jul 12, 1999 after 84 days
- Product code: IYE (Accelerator, Linear, 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: 3 generations back to K935300 (1994). 8 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960338: Stereotactic Body Frame, Elekta Instrument AB (1996) Summary page 2.
- K970291: Accessories to the Stereotactic Body Fram, Elekta Instrument AB (1997) Summary page 2.
- K982463: Extracranial Radiotherapy System, Howmedica, Inc. (1998) Summary page 2.

## Most influential descendants
- K100691: Omni V SBRT Positioning System, Model RT-4500 (2010), 6 descendants of its own
- K122888: CDR Systems Precision Patient Positioning System (2013), 5 descendants of its own
- K153026: Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge Replacement (2016), 3 descendants of its own
- K210894: Siddharth-II; Impact (2021), 1 descendant of its own
- K222762: Siddharth-II;Impact (2023), 0 descendants of its own

## Indications for use
This is to certify that the BodyLocm" Whole Body Stereotactic Localizer System For Radiotherapy, as submitted under the above referenced 510(k) number, is indicated for use as a precision patient immobilization and positioning system for the purpose of performing diagnostic localization and fractionated stereotactic radiotherapy/ radiosurgery treatment. It is substantially equivalent to similar devices which are used to position the body during stereotactic radiotherapy of various body lesions. The decision and conditions under which the system is to be used is made by the patient’s managing physician(s).

Source page: https://510kreport.com/device/K991336
Methodology: https://510kreport.com/methodology