# K964438: 511 Kev Collimator

- Pathway: 510(k) (Traditional)
- Applicant: Trionix Research Laboratory, Inc.
- Decided: May 29, 1997 after 205 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- 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 K873775 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K873775: Triad Nuclear Imaging System, Trionix Research Laboratory, Inc. (1988) Summary page 2.
- K920776: Cardiac Triad Nuclear Imaging System, Trionix Research Laboratory, Inc. (1992) Summary page 3.
- K923345: Biad New Detector Option, Trionix Research Laboratory, Inc. (1992) Summary page 3.

## Indications for use
To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). Could be used with 511 keV photon imaging and photons of smaller energy simutaneously (e,q. 140 keV and 511 keV) To detect or image the distribution of radionuclides in the body or organ, using the following techniquc(s). Could be used with 511 keV photon imaging and photons ol smaller enerqgy simutaneously (e.g 140 keV an 511 keV)

Source page: https://510kreport.com/device/K964438
Methodology: https://510kreport.com/methodology