510(k) · Cleared
ClearedModification to: Sens-a-Ray System with Proimage Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afp Imaging Corp. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Oct 16, 2001 as substantially equivalent to K923067 (Regam Medical Systems, 1992) after a 22-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 16, 2001
- Review
- 22 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923067 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK923067 Sens-a-RayRegam Medical Systems · 1992
- This deviceK013176 Modification to: Sens-a-Ray System with Proimage SoftwareAfp Imaging Corp. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923067 | Sens-a-Ray | Regam Medical Systems | 1992 | — |
| 0 (this device) | K013176 | Modification to: Sens-a-Ray System with Proimage Software | Afp Imaging Corp. | 2001 | — |
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 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? (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 |
|---|---|---|---|
| * | K923067 | Sens-a-RaySummary page 1…al Name: Accessory to Extraoral X-Ray System Classification Name: Extraoral Source X-Ray System Accessory 3. PREDICATE DEVICES AFP Imaging Corporation Sens-A-Ray System K923067 4, DEVICE DESCRIPTION The Prolmage Software is essentially identical to the Sens-A-Ray software described in K923067. (K923067… | 1992 |
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.
- 1 other device also cites its predicate K923067.
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 AFP Imaging Sens-A-Ray Digital Dental X-Ray System with Prolmage Software is intended for use with standard digital dental X-ray systems and computer stations for system operation, archive data storage, image capture and enhancement, and patient data and support.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013176 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013176: Modification to: Sens-a-Ray System with Proimage Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013176
Report an extraction error
Are you the manufacturer?
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