510(k) · Cleared
ClearedCeph, Model 4900
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schick Technologies, Inc. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Feb 17, 2006 as substantially equivalent to K837506 (Eastman Kodak Company, 1983) and 2 other predicates after a 58-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Feb 17, 2006
- Review
- 58 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K933455 (1994). 4 ancestors in all, the oldest K837506 (1983). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −1 | K041385 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2004 | — |
| 0 (this device) | K053558 | Ceph, Model 4900 | Schick Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2003 | 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 |
|---|---|---|---|
| * | K837506 | Kodak T-Mat G Film SO-381Summary page 1…718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: December 1, 2005 A. Legally Marketed Predicate Devices KODAK T-MAT G FILM SO-381 (K837506) is a legally marketed predicate receptor that is indicated for cephalometric examinations. The CDR PANX, MODEL 4792 (K031291) is… | 1983 |
| * | K031291 | CDR Panx, Model 4792Summary page 1…edicate Devices KODAK T-MAT G FILM SO-381 (K837506) is a legally marketed predicate receptor that is indicated for cephalometric examinations. The CDR PANX, MODEL 4792 (K031291) is a legally marketed predicate x-ray generator indicated for extra-oral dental exams, and will be utilized as the host generato… | 2003 |
| * | K041385 | Modification to Computed Oral Radiology SystemSummary page 1…ntal exams, and will be utilized as the host generator on the Ceph Model 4900. The integrated software is similar to that utilized in the COMPUTED ORAL RADIOLOGY SYSTEM (K041385). B. Device Description The Ceph Model 4900 is intended to replace x-ray film in the acquisition of diagnostic cephalometric x-… | 2004 |
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?
- The line of descent spans 12 years and passes through 1 company; a new generation was cleared every 10.3 years on median.
- None of the 4 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 Ceph Model 4900 is indicated for individuals requiring extra-oral dental examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053558 · printed Nov 5, 2026
Cite this page
510(k) Report. “K053558: Ceph, Model 4900.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K053558
Report an extraction error
Are you the manufacturer?
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