510(k) · Cleared
ClearedApex Hri Digital Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Krugman Technologies, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Dec 13, 2002 as substantially equivalent to K950532 (Trophy Radiologie, 1995) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Dec 13, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K933455 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- This deviceK023292 Apex Hri Digital Radiography SystemKrugman Technologies, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| 0 (this device) | K023292 | Apex Hri Digital Radiography System | Krugman Technologies, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K950532 | Trophy Radiologie RVG Portable RadiovisiographySummary page 1…ction 892.1800) This is a Class 11device Plwluct code MUH Substantiallv Equivalent Devices: Trophy Radiologie RVG Portable Radiovisiography K950532 Mediadent HDXMMD HDX SP m y sensor KO02425 Computed Oral Radiology System K933455 Device Descrivtion: Digital dental IntraoralXr… | 1995 |
| * | K002425 | Mediadent HDX/MMD HDX SP Xray Sensor | 2000 |
| * | K933455 | Computed Oral Radiology SystemSummary page 1…MUH Substantiallv Equivalent Devices: Trophy Radiologie RVG Portable Radiovisiography K950532 Mediadent HDXMMD HDX SP m y sensor KO02425 Computed Oral Radiology System K933455 Device Descrivtion: Digital dental IntraoralXray sensor Intended Use: This device is used to take dental intraoraldiagnosticxmy… | 1994 |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K950532.
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.
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 Apex HRI Digital Radiography System is designed to replace standard intraoral x-ray film and film development chemicals used for patient diagnostics in dental practices. The Apex HRI Digital Xray Sensor is covered with a sterile disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray. The dental x-ray tube (which is NOT part of this product) is pointed at the sensor and activated. The emitted radiation from…
Read the full statement (137 words)
The Apex HRI Digital Radiography System is designed to replace standard intraoral x-ray film and film development chemicals used for patient diagnostics in dental practices.
The Apex HRI Digital Xray Sensor is covered with a sterile disposable sheath and positioned in the oral cavity opposite the tooth the dentist wishes to x-ray. The dental x-ray tube (which is NOT part of this product) is pointed at the sensor and activated.
The emitted radiation from the x-ray tube is detected by the sensor and transmitted as a data stream to the computer system that the device is connected to. The imaging software interprets the data stream and displays it as a grey scale image on the monitor of the connected computer system. The grey scale image is the digitally formed x-ray the dentist will then use for diagnostics.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023292 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023292: Apex Hri Digital Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023292
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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