# K071360: Optical Guidance Platform

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Jun 8, 2007 after 24 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971675 (1997). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971675: SNT Stereotactic Localization System, Surgical Navigation Technologies, Inc. (1997) Summary page 1.
- K971893: SNT Linac Accessories, Surgical Navigation Technologies, Inc. (1997) Summary page 1.
- K980750: Radiocameras Patient Positioning System, Surgical Navigation Technologies, Inc. (1998) Summary page 1.
- K981346: Radiocameras Biteblock Localization and Positioning System, Surgical Navigation Technologies, Inc. (1998) Summary page 1.
- K994355: Radiocameras System Head/Neck Application, Surgical Navigation Technologies, Inc. (2000) Summary page 1.
- K000246: Radiocameras Extracranial System, Surgical Navigation Technologies, Inc. (2000) Summary page 1.

## Most influential descendants
- K142560: Varian Head Frame (2014), 1 descendant of its own
- K180586: Varian Head Frame (2018), 0 descendants of its own

## Recalls of this device
- Oct 4, 2011 · Not classified · Z-0332-2012: An anomaly has been identified with the Head Ring posts used by both the Optical Guidance Platform FrameArray module and the Floorstand where the head ring posts may be damaged due to excessive mechan
- Mar 30, 2011 · Not classified · Z-2200-2011: A software anomaly has been identified with the Optical Guidance Platform (OGP) Software v2.6 and v2.6.1 where the transfer of datasets from treatment planning systems other than the FastPlan system r
- Mar 3, 2011 · Not classified · Z-2063-2011: The optical guidance platform may not be properly enforcing a 24 hour time limit between optical camera recalibrations.
- Mar 3, 2011 · Not classified · Z-2176-2011: The anomaly that has been identified with the Optical Guidance Platform (OGP) software may not be always displaying the correct transfer date on the patient file.
- Jan 26, 2009 · Not classified · Z-0888-2011: Potential patient impact -- limit switches for Floorstand may be inadequate for some models and allow for potential impact.

## Indications for use
Varian Medical System's Optical Guidance Platform (OGP) is for use with a charged particle accelerator to perform precise positioning of treatment target for stereotactic radiosurgery or radiotherapy treatments on cranial or extracranial lesions.

Source page: https://510kreport.com/device/K071360
Methodology: https://510kreport.com/methodology