VANTAGE MODEL V5000, V5100, V5000C, V5100C— 510(k) K122643
Substantially EquivalentMidmark Corp.
FDA 510(k) clearance K122643 for VANTAGE MODEL V5000, V5100, V5000C, V5100C, Substantially Equivalent on 2013-01-07. Applicant: Midmark Corp.. Device class: 2.
Clearance details
- Applicant
- Midmark Corp.
- Product code
- Code MUH
- Device class
- Class 2
- Regulation
- 21 CFR 872.1800
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
Recent devices under product code MUH
view allMore clearances from Midmark Corp.
view allRecalls naming K122643
K-number listed on FDA's recall record- Z-0651-2016 — Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used 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 evalu
- Z-0651-2014 — The Vantage Digital Panoramic System delivers high-value features standard on every system: - Five pre-programmed exam settings, including bitewing, minimize exam set-up time and allow routine diagnostic exams to be performed extraorally for improved clinical efficiency and patient experience. - Progeny Clarity Enhanced Filter Set provides superior diagnostic imaging quality - Exclusive Focal Trough Alignment reminder assists in consistent patient positioning - Progeny Imaging software included for download on an unlimited number of operatory workstations with no additional costs - Exclusive VantageTrust remote support and training service offered at no charge for the first 60 days of use - Ceph upgradeable for expanded extraoral exam capabilities - The Progeny Vantage Panoramic System s proudly designed and manufactured in the USA; 2013 Midmark Corporation; 675 Heathrow Drive Lincolnshire, IL 60069; 847-415-9800 Toll-free 888-924-3800
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122643.
Data sourced from openFDA. This site is unofficial and independent of the FDA.