# K040870: Shimadzu Image Amplifier, Model IA-16L/HS

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: May 17, 2004 after 45 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.
- (no number) IA-16LM: named in the summary without a submission number

## Indications for use
This device is intended to be used in the fluoroscopy and fluorography. This device is operated and used by Physicians and X-ray technologist. The object of this device is total patient population. As mentioned at "Intended Use" in this notification, the intended use of the IA-16L/HS is the same as that of predicate device IA-16LM. Consequently, the indications for use of the IA-16L/HS are also the same as that of the IA-16LM and there are no additional indications.

Source page: https://510kreport.com/device/K040870
Methodology: https://510kreport.com/methodology