510(k) · Cleared
ClearedScanaray/CD-Dent Advanced Computerized X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afp Imaging Corp. · LMA Digitizer, Image, Radiological
Cleared on Feb 25, 1998 as substantially equivalent to K934949 (Orion Corporation Soredex, 1994) and 1 other predicate after a 76-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.
- Decided
- Feb 25, 1998
- Review
- 76 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K884621 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK884621 DigiscanSiemens Medical Solutions USA, Inc. · 1989
- 1 generation backK955643 Alara Imaging SystemDenoptix, Inc. · 1996
- This deviceK974619 Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998
- Descendant · cites it directly · 0 of its ownK990049 CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models…Digident, Ltd. · 1999
Most influential descendants
Showing 1 of 1 · See all- K990049CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000Digident, Ltd. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884621 | Digiscan | Siemens Medical Solutions USA, Inc. | 1989 | — |
| −1 | K955643 | Alara Imaging System | Denoptix, Inc. | 1996 | — |
| 0 (this device) | K974619 | Scanaray/CD-Dent Advanced Computerized X-Ray System | Afp Imaging Corp. | 1998 | — |
| +1 | K990049 | CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and… | Digident, Ltd. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 3 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 LMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K934949 | DigoraSummary page 1…Electrostatic X-Ray imaging system 5. PREDICATE DEVICES The legally marketed devices to which equivalence is being claimed are: . Digora marketed by Sorodex-finndent (K934949) . DerOptix System marketed by Gendex (K955643) 6. DEVICE DESCRIPTION The ScanARay Advanced Computerized X-Ray System is a film… | 1994 |
| * | K955643 | Alara Imaging SystemSummary page 1…TE DEVICES The legally marketed devices to which equivalence is being claimed are: . Digora marketed by Sorodex-finndent (K934949) . DerOptix System marketed by Gendex (K955643) 6. DEVICE DESCRIPTION The ScanARay Advanced Computerized X-Ray System is a filmless system intended for digital intraoral and… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990049 | CD-Dent Digital Imaging Devices for Dental X-Ray Systems, Models 600, 1000 and 2000 | 1999 | 0 |
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 9 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K990049 (Digident, Ltd., 1999) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K934949.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ScanARay Advanced Computerized X-Ray System is intended for digital dental
radiography using a phosphor storage screen for radiographic diagnostic intraoral and
extraoral exposures.
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/K974619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974619: Scanaray/CD-Dent Advanced Computerized X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974619
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