510(k) · Cleared
ClearedCDR - Pan Model 4700
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schick Technologies, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Dec 11, 1998 after a 134-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 4 later devices descend from it.
- Decided
- Dec 11, 1998
- Review
- 134 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 3 citing it directly.
- This deviceK982661 CDR - Pan Model 4700Schick Technologies, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK031801 Pantos, Models: Pantos 16, and Pantos DGBlue X Imaging Srl · 2003
- Descendant · 2 generations on · 0 of its ownK161131 FONA Pan/CephFona S.R.L · 2016
- Descendant · cites it directly · 0 of its ownK111103 Digital X-Ray Imaging SystemRf Co., Ltd. · 2012
- Descendant · cites it directly · 0 of its ownK021542 Adc DentalAgfa Corp. · 2002
Most influential descendants
Showing 4 of 4 · See all- K031801Pantos, Models: Pantos 16, and Pantos DGBlue X Imaging Srl · 2003 · cites it directly1descendant
- K161131FONA Pan/CephFona S.R.L · 2016 · 2 generations on0descendants
- K111103Digital X-Ray Imaging SystemRf Co., Ltd. · 2012 · cites it directly0descendants
- K021542Adc DentalAgfa Corp. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982661 | CDR - Pan Model 4700 | Schick Technologies, Inc. | 1998 | — |
| +1 | K031801 | Pantos, Models: Pantos 16, and Pantos DG | Blue X Imaging Srl | 2003 | — |
| +2 | K161131 | FONA Pan/Ceph | Fona S.R.L | 2016 | — |
| +1 | K111103 | Digital X-Ray Imaging System | Rf Co., Ltd. | 2012 | — |
| +1 | K021542 | Adc Dental | Agfa Corp. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (4)
3 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?
- Of its descendants, K031801 (Blue X Imaging Srl, 2003) has gone furthest, with 1 descendant of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The CDR-PAN Panoramic Dental Digital Imager is indicated for use in acquiring radiographic images at the dento-maxillofacial region. It is intended to replace radiographic film/screen systems in panoramic dental diagnostic procedures.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982661 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982661: CDR - Pan Model 4700.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982661
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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