# K963730: Protec (1024)

- Pathway: 510(k) (Traditional)
- Applicant: Proportional Technologies, Inc.
- Decided: Feb 10, 1997 after 147 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) SIM-400: named in the summary without a submission number
- (no number) Xenos Mobile Cam: named in the summary without a submission number

## Indications for use
The general indication for use is in imaging human organs through use of injected radiopharmaceuticals, which are separately regulated as diagnostic drugs. The device will have a wide variety of applications in planar single organ and whole body imaging.

Source page: https://510kreport.com/device/K963730
Methodology: https://510kreport.com/methodology