# K060532: HDR 1000 Plus Well Chamber, Model 90008

- Pathway: 510(k) (Traditional)
- Applicant: Standard Imaging, Inc.
- Decided: Apr 11, 2006 after 42 days
- Product code: JAQ (System, Applicator, Radionuclide, Remote-Controlled)
- Device class: 2
- Regulation: 21 CFR 892.5700
- 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)
- K001825: Standard Imaging HDR 1000 Plus Ion Chamber; Standard Imaging Ivb 1000 Ion Chamber, Standard Imaging, Inc. (2000)
- K922554: Standard Imaging HDR 1000 Ion Chamber, Standard Imaging, Inc. (1992) Summary page 1.

## Indications for use
The Standard Imaging HDR 1000 Plus Well Chamber is a well-type chamber. It is specifically designed to measure the amount of radiation of brachytherapy sources, including high-dose-rate (HDR), low-dose-rate (LDR), intravascular (IVB) and electronic (x-ray) sources, with the appropriate calibration from an accredited dosimetry calibration laboratory. Sources must be measured using the appropriate and specific source holder as described in the labeling.

Source page: https://510kreport.com/device/K060532
Methodology: https://510kreport.com/methodology