510(k) · Cleared
ClearedPromax, Panoramic X-Ray Unit with Cephalostat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Planmeca Oy · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jun 29, 2001 after a 35-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Jun 29, 2001
- Review
- 35 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK011619 Promax, Panoramic X-Ray Unit with CephalostatPlanmeca Oy · 2001
- Descendant · cites it directly · 1 of its ownK122643 Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 2013 · Recalled
- Descendant · cites it directly · 1 of its ownK051464 Planmeca Promax with Dec (Dynamic Exposure Control)Planmeca Oy · 2005
- Descendant · 2 generations on · 0 of its ownK201667 Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020
- Descendant · cites it directly · 0 of its ownK091866 Progeny Vantage Panoramic X-Ray SystemMidmark · 2009
- Descendant · 2 generations on · 0 of its ownK072244 Planmeca ProonePlanmeca Oy · 2007
Most influential descendants
Showing 5 of 5 · See all- K122643Vantage Model V5000, V5100, V5000C, V5100CMidmark Corp. · 2013 · cites it directly1descendant
- K051464Planmeca Promax with Dec (Dynamic Exposure Control)Planmeca Oy · 2005 · cites it directly1descendant
- K201667Midmark Extraoral Imaging System (EOIS)Midmark Corporation · 2020 · 2 generations on0descendants
- K091866Progeny Vantage Panoramic X-Ray SystemMidmark · 2009 · cites it directly0descendants
- K072244Planmeca ProonePlanmeca Oy · 2007 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011619 | Promax, Panoramic X-Ray Unit with Cephalostat | Planmeca Oy | 2001 | — |
| +1 | K122643 | Vantage Model V5000, V5100, V5000C, V5100C | Midmark Corp. | 2013 | 2 |
| +1 | K051464 | Planmeca Promax with Dec (Dynamic Exposure Control) | Planmeca Oy | 2005 | — |
| +2 | K201667 | Midmark Extraoral Imaging System (EOIS) | Midmark Corporation | 2020 | — |
| +1 | K091866 | Progeny Vantage Panoramic X-Ray System | Midmark | 2009 | — |
| +2 | K072244 | Planmeca Proone | Planmeca Oy | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2020 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EHD? 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 EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K122643 (Midmark Corp., 2013) has gone furthest, with 1 descendant of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, 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 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The ProMax, Panoramic X-ray Imaging System with Cephalostat, is an extraoral source X-ray System, which is intended for dental radiographic examination and diagnosis of discases of the teeth, jaw, and oral structures. The device can be equipped with accessories to fulfil different diagnostic needs. In digital configuration the images are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K011619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K011619: Promax, Panoramic X-Ray Unit with Cephalostat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011619
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026