# K122643: Vantage Model V5000, V5100, V5000C, V5100C

- Pathway: 510(k) (Traditional)
- Applicant: Midmark Corp.
- Decided: Jan 7, 2013 after 131 days
- Product code: MUH (System, X-Ray, Extraoral Source, Digital)
- Device class: 2
- Regulation: 21 CFR 872.1800
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K973642 (1997). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043612: Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D, Instrumentarium Corp. Imaging Division (2005) Summary page 1.
- K011619: Promax, Panoramic X-Ray Unit with Cephalostat, Planmeca Oy (2001) Summary page 1.

## Most influential descendants
- K201667: Midmark Extraoral Imaging System (EOIS) (2020), 0 descendants of its own

## Recalls of this device
- Sep 4, 2014 · Class II · Z-0651-2016: Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
- Sep 20, 2013 · Class II · Z-0651-2014: An error was identified in the Real Time Controller (RTC) firmware versions 3.0, 3.1, 3.2, and 3.3 used in Vantage Panoramic X-Ray systems. The error may cause the column of the Vantage Panoramic X-Ra

## Indications for use
The indications for use of the Progeny Vantage Panoramic X-Ray System is to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evaluation.

Source page: https://510kreport.com/device/K122643
Methodology: https://510kreport.com/methodology