510(k) · Cleared
ClearedPhot-X II, Model 303
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Takara Belmont USA, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 7, 2004 as substantially equivalent to K874238 (Belmont Equipment Corp., 1987) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1987. 2 later devices descend from it.
- Decided
- Sep 7, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K874238 (1987). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK874238 Model 2001 CP, Photon I, Dental, Intraoral X-RayBelmont Equipment Corp. · 1987
- This deviceK042260 Phot-X II, Model 303Takara Belmont USA, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK190357 Star-X, Intraoral X-ray SystemHdx Will Corp. · 2019
- Descendant · cites it directly · 0 of its ownK141293 Phot-X Iis Model 505Takara Belmont Corporation · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874238 | Model 2001 CP, Photon I, Dental, Intraoral X-Ray | Belmont Equipment Corp. | 1987 | — |
| 0 (this device) | K042260 | Phot-X II, Model 303 | Takara Belmont USA, Inc. | 2004 | — |
| +1 | K190357 | Star-X, Intraoral X-ray System | Hdx Will Corp. | 2019 | — |
| +1 | K141293 | Phot-X Iis Model 505 | Takara Belmont Corporation | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 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 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K874238 | Model 2001 CP, Photon I, Dental, Intraoral X-RaySummary page 1…MER (per 21 CFR section 872.1800) (3)PREDICATE DEVICE: Substantial equivalence isbased on following legally marketed devices. Belmont, MODEL 2001 CP (K874238) Sirona, HELIODENT DS (K960819) Planmeca, PROSTYLE INTRA (K970975) (4) DESCRIPTION OF THE DEVICE… | 1987 |
| * | K960819 | Heliodent DSSummary page 1…PREDICATE DEVICE: Substantial equivalence isbased on following legally marketed devices. Belmont, MODEL 2001 CP (K874238) Sirona, HELIODENT DS (K960819) Planmeca, PROSTYLE INTRA (K970975) (4) DESCRIPTION OF THE DEVICE: PHOT-X II,MODEL 303 dental x-ray contains;… | 1996 |
| * | K970975 | Prostyle IntraSummary page 1…d on following legally marketed devices. Belmont, MODEL 2001 CP (K874238) Sirona, HELIODENT DS (K960819) Planmeca, PROSTYLE INTRA (K970975) (4) DESCRIPTION OF THE DEVICE: PHOT-X II,MODEL 303 dental x-ray contains; control box, wall mounting, adjus… | 1997 |
What descends from it? (2)
2 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K190357 (Hdx Will Corp., 2019) has gone furthest, with 0 descendants 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?
PHOT-X II MODEL 303 is a extraoral source dental radiographic x-ray unit. This unit works
as a diagnostic purpose x-ray source for human teeth with the resultant image recorded on
intraoral dental x-ray film or image receptor. The design, function and positioning of the x-ray
unit is similar to most all other x-ray machines manufactured for this specific purpose over the
past thirty years.
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/K042260 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042260: Phot-X II, Model 303.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042260
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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