# K992303: Sonographic Planning of Oncology Treatments (Spot), Model V.. 1.0

- Pathway: 510(k) (Traditional)
- Applicant: Nucletron Corp.
- Decided: Mar 27, 2000 after 263 days
- Product code: MUJ (System, Planning, Radiation Therapy Treatment)
- 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: 1 generation back to K911612 (1991). 2 ancestors in all.
6 later devices descend from it; 2 cite 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)
- K911612: Nucletron Planning System, Nucletron-Oldelft Corp. (1991). Our OCR of the scanned summary read K811612, FDA’s number for Tryptic Soy Agar (Micro Media Laboratories). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Nucletron Planning System”.
- K961403: Life Imaging Systems Lis 6000 a, Life Imaging Systems, Inc. (1996) Summary page 1.

## Cited in the summary but kept off the family tree
- K915562: PLATO Brachytherapy Planning System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K022739: Real Time HDR (220V), Model 132.001; Real Time HDR (110V), Model 132.002 (2002), 4 descendants of its own
- K031158: Swift 2.0, Model 132.001 (2003), 3 descendants of its own
- K022741: Spot Pro (220V), Model 131.099 (2002), 2 descendants of its own
- K112420: Oncentra Prostate 4.0 (2011), 1 descendant of its own
- K170841: BiopSee, Mobile US (2017), 0 descendants of its own

## Indications for use
Brachytherapy planning, utilizing 3D Ultrasound Imaging, Sonographic Planning of Oncology Treatments (SPOT) is intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving manual or remote afterloading radioactive sources. The software program provides the physician with anatomical and dosimetric information to determine the positioning and loading of the radioactive sources prior to insertion. From this information the patient can be treated with radioactive sources.

Source page: https://510kreport.com/device/K992303
Methodology: https://510kreport.com/methodology