# K973430: Kodak Pro-Medical Digital Camera System

- Pathway: 510(k) (Traditional)
- Applicant: Eastman Kodak Company
- Decided: Jul 17, 1998 after 310 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- 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.

## Indications for use
The camera is intended to digitally capture images for micro-surgery, pathology, micro-biology, ophthalmology and general surgery applications. Upon capturing the image, it is stored in the memory of the PCMCIA Card in the camera. User may utilize the audio function of the camera to record patient, exam or any other pertinent identification information. The Camera is connected to the computer via the high speed serial bus (IEEE 1394) cable interface. The images are viewed, selected and then downloaded using Twain Compliant” Driver for PCs and Adobe Photoshop Plug-in Software for MACINTOSH based systems. The user will be able to annotate and format the images and add information prior to transmission and/or archiving. The camera is capable of both lossy and lossless data compression. The operator is instructed in the manual to utilize only lossless data compression for medical applications.

Source page: https://510kreport.com/device/K973430
Methodology: https://510kreport.com/methodology