# K013689: RE-Entrant Chamber

- Pathway: 510(k) (Traditional)
- Applicant: Sun Nuclear Corp.
- Decided: Jul 2, 2002 after 238 days
- Product code: KPT (Calibrator, Dose, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.1360
- 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 K922554 (1992). 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)
- K922554: Standard Imaging HDR 1000 Ion Chamber, Standard Imaging, Inc. (1992) Summary page 1.
- K001825: Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber, Standard Imaging, Inc. (2000)

## Indications for use
The Model 1008 (&ID as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (1VB) sources. Both types of IVk sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement'Quallty Assurance program in order to validate the chamber calibration over a period of time,

Source page: https://510kreport.com/device/K013689
Methodology: https://510kreport.com/methodology