510(k) · Cleared
Recalled · Class II · 2014Vantage Model V5000, V5100, V5000C, V5100C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Midmark Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Jan 7, 2013 as substantially equivalent to K043612 (Instrumentarium Corp. Imaging Division, 2005) and 1 other predicate after a 131-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jan 7, 2013
- Review
- 131 days
- Class
- Class II
- Product code
- MUH
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973642 (1997). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 1 generation backK043612 Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005
- This deviceK122643 Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 2013
- Descendant · cites it directly · 0 of its ownK201667 Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020
Most influential descendants
Showing 1 of 1 · See all- K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −1 | K043612 | Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200D | Instrumentarium Corp. Imaging Division | 2005 | — |
| 0 (this device) | K122643 | Vantage Model V5000, V5100, V5000C, V5100C | Midmark Corp. | 2013 | — |
| +1 | K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043612 | Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DSummary page 1…System, x-ray, extraoral source, digital (21 CFR 872.1800, Product Code MUH) Predicate Devices: Instrumentarium Orthopantomograph OP200D (K043612) Planmeca ProMax (K011619) Description of Device: The Progeny Vantage Panoramic X-Ray System is an ex… | 2005 |
| * | K011619 | Promax, Panoramic X-Ray Unit with CephalostatSummary page 1…(21 CFR 872.1800, Product Code MUH) Predicate Devices: Instrumentarium Orthopantomograph OP200D (K043612) Planmeca ProMax (K011619) Description of Device: The Progeny Vantage Panoramic X-Ray System is an extraoral radiographic imagi… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K201667 | Midmark Extraoral Imaging System (EOIS) | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2014 | Class II | Z-0651-2016 | Device Design | 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 | Software design | 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-Ray unit to continue moving vertically… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K201667 (Midmark Corporation, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K043612.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122643: Vantage Model V5000, V5100, V5000C, V5100C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122643
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026