510(k) · Cleared
ClearedInfimed Dental System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infimed, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 11, 1997 after a 444-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 11, 1997
- Review
- 444 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
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.
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?
InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information. Its capabilities include: Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a…
Read the full statement (130 words)
InfiMed Dental System is an image acquisition and management system that allows acquisition, processing, display, and print of filmless radiographs and/or color dental images. It consists of various components that acquire, store, display, and print radiographs and/or color dental images with patient information.
Its capabilities include:
Color image acquisition takes place from a standard S-video color camera. Radiograph acquisition takes place from a Charge Coupled Device (CCD) camera designed for the application. Images can be directly printed and displayed on standard s-video equipment or transferred to a personal computer for acquisition and storage. If images are stored on the personal computer, dental image management software is utilized for patient data input, image processing, and image display on the computer monitor. In addition, printed reports are available from the personal 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/K962422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962422: Infimed Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962422
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026