510(k) · Cleared
ClearedRTLX
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infimed, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Mar 31, 2000 as substantially equivalent to K943532 (Panoramic Corp., 1994) and 2 other predicates after a 256-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Mar 31, 2000
- Review
- 256 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K881133 (1989). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK881133 70-X/RVG (Radiovisiography)Trophy Radiologie · 1989
- This deviceK992392 RTLXInfimed, Inc. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881133 | 70-X/RVG (Radiovisiography) | Trophy Radiologie | 1989 | — |
| 0 (this device) | K992392 | RTLX | Infimed, Inc. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 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 |
|---|---|---|---|
| * | K943532 | Panoramic Corporation HDLXSummary page 2…evices and comparison: P r { ®) o 75/7( y e e s €go~ Feature/System Panoramic RTLX | Panoramic HDLX | Schick Trophy Radiologie Technologies CDR | RVG-S 510(k) number N/A K943532 K933455 K881133 X-ray Energy Source 70kV/ 100uA 70kV/ 100pA N/A (X-ray source N/A (X-ray source dependent) dependent) Image Acqui… | 1994 |
| * | K933455 | Computed Oral Radiology SystemSummary page 2…nd comparison: P r { ®) o 75/7( y e e s €go~ Feature/System Panoramic RTLX | Panoramic HDLX | Schick Trophy Radiologie Technologies CDR | RVG-S 510(k) number N/A K943532 K933455 K881133 X-ray Energy Source 70kV/ 100uA 70kV/ 100pA N/A (X-ray source N/A (X-ray source dependent) dependent) Image Acquisition s… | 1994 |
| * | K881133 | 70-X/RVG (Radiovisiography)Summary page 2…rison: P r { ®) o 75/7( y e e s €go~ Feature/System Panoramic RTLX | Panoramic HDLX | Schick Trophy Radiologie Technologies CDR | RVG-S 510(k) number N/A K943532 K933455 K881133 X-ray Energy Source 70kV/ 100uA 70kV/ 100pA N/A (X-ray source N/A (X-ray source dependent) dependent) Image Acquisition speed | 2… | 1989 |
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.
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 RTLX is a digital dental X-ray system with an intra-oral electronic sensor. Its intended use is to provide real-time x-ray images for dentists with a low X-ray dose By producing real-time imaging, the RTLX provides immediate information in the course of operative treatment, such as information on the position of instruments in internal structures.
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/K992392 · printed Nov 5, 2026
Cite this page
510(k) Report. “K992392: RTLX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992392
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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