510(k) · Cleared
ClearedThe Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flow X-Ray Corp. · EAP Unit, X-Ray, Intraoral
Cleared on Sep 27, 2005 as substantially equivalent to K896024 (Mdt Diagnostic Co., 1990) after a 25-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Sep 27, 2005
- Review
- 25 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K896024 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK896024 MDT/Castle Model HDX Dental X-Ray MachineMdt Diagnostic Co. · 1990
- This deviceK052422 The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)Flow X-Ray Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K896024 | MDT/Castle Model HDX Dental X-Ray Machine | Mdt Diagnostic Co. | 1990 | — |
| 0 (this device) | K052422 | The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) | Flow X-Ray Corp. | 2005 | — |
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 EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K896024 | MDT/Castle Model HDX Dental X-Ray MachineSummary page 1…X-Ray Machines (Wall Mounted and Mobile) Common ojrUsual Name: Intraoral Dental X-Ray Unit 3. Predicate Device Information: K#896024, MDT/Castle Model HDX Dental X-Ray Machine; MDT Diagnostic Co., Rochester, NY 4. Device Description:… | 1990 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EnVision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile) are intended to be used only for intraoral radiography of dental anatomy for diagnostic purposes performed by professionally trained and licensed personnel on the use of the system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052422: The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052422
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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