# K012424: Shimadzu Image Amplifier Model # IA-16LM

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: Oct 18, 2001 after 80 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
Longest line of descent: 1 generation back to K984111 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984111: FV-RF, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 3.

## 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 populations. As mentioned at “Intended Use” in this notification, the intended use of the IA-16LM is the same as that of predicate device IA-16VMA12 in KV-RF (K984111). Consequently, the indications for use of the IA-16LM are also the same as that of the IA-16VMA12 in KV-RF (K984111) and there are no additional indications.

Source page: https://510kreport.com/device/K012424
Methodology: https://510kreport.com/methodology