# K063716: Aerosol System

- Pathway: 510(k) (Traditional)
- Applicant: Amici, Inc.
- Decided: Dec 28, 2007 after 379 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 K865084 (1987). 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)
- K873930: Aerosol Delivery System (Aero-Tech II), Cadema Medical Products, Inc. (1987) Summary page 1.
- K865084: Amici Xenon Rebreathing System*, Amici, Inc. (1987) Summary page 1.

## Indications for use
The AeroSol T m Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.

Source page: https://510kreport.com/device/K063716
Methodology: https://510kreport.com/methodology