# K972019: Pefect Shot

- Pathway: 510(k) (Traditional)
- Applicant: International Imaging Electronics
- Decided: Jul 3, 1997 after 32 days
- Product code: EIA (Unit, Operative Dental)
- Device class: 1
- Regulation: 21 CFR 872.6640
- 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 Perfect Shot Intra-Oral Cameéra is to be used by medical practitioners, usually dental hygienists, assistants or dentists, to view the mouth of patients. It can explore the entire mouth and examine teeth or.gum tissue for diagnostic purposes. It is distributed through dealers to medical practitioners. The Perfect Shot is wireless, unlike other similar devicas, allowing more freedam of movement by the user. It also contains voice activated instructions which enable the user to “freeze” a view on the monitor or take a picture (capture and print) of the area being examined for reference at a later date by simply using voice instructions. The product is designed to transmit a RF (radio frequency) signal to a receiver. This product can and will be used both intra and extra orally, which will allow a dentist to examine and display to the patient problem areas of concern or treatment that is required. The resolution capabilities of the CCD (Charge Coupled Device) is 640480 lines. The picture is transmitted to a monitor in the examination area for the patient to view, allowing the patient a better undarstanding of a potential problem and a better explanation of the prescribed solution. Pictures that are captured-may be printed for further review or for patient files. The Perfect Shot may also be attached to computers for digital storage or transmission to other computers.

Source page: https://510kreport.com/device/K972019
Methodology: https://510kreport.com/methodology