510(k) · Cleared
ClearedEva Select Digital Dental Imaging System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afp Imaging Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Dec 27, 2012 as substantially equivalent to K030647 (Afp Imaging Corp., 2003) and 1 other predicate after a 51-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Dec 27, 2012
- Review
- 51 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K933455 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 4 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 3 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 2 generations backK090458 Dexis SensorDexis, LLC · 2009
- 1 generation backK102456 Intraoral Belsensor GoldTakara Belmont USA, Inc. · 2011
- This deviceK123419 Eva Select Digital Dental Imaging SystemAfp Imaging Corp. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −4 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −3 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −2 | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| −1 | K102456 | Intraoral Belsensor Gold | Takara Belmont USA, Inc. | 2011 | — |
| 0 (this device) | K123419 | Eva Select Digital Dental Imaging System | Afp Imaging Corp. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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? (3)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030647 | Eva Digital Dental X-Ray SystemSummary page 1…a oral Source X-Ray System Accessory Classification Code: MUH 2. PREDICATE DEVICES * AFP Imaging EVA Digital Dental Imaging System K030647 * Midmark Clearvision Ki 12380 " Takara Belmont Belsensor Gold K1 02456 3. Intended Use The… | 2003 |
| Kept off the family tree | K012380 | FDA’s K012380 is Modification to: Stryker Navigation System, Stryker Fluoroscopy System,Virtual… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2001 |
| * | K102456 | Intraoral Belsensor GoldSummary page 1…PREDICATE DEVICES * AFP Imaging EVA Digital Dental Imaging System K030647 * Midmark Clearvision Ki 12380 " Takara Belmont Belsensor Gold K1 02456 3. Intended Use The EVA SELECT Digital Dental Imaging System is intended to be used with standard… | 2011 |
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?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 9 ancestors has a recall.
- 1 other device also cites its predicate K030647.
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. 2012, 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 EVA SELECT Digital Dental Imaging System is intended to be used
with standard dental X-ray systems and computer stations for system operation, archive data
storage, digital dental image input capture and enhancement, and patient data and support.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123419: Eva Select Digital Dental Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123419
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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