510(k) · Cleared

Cleared

Alara Imaging System

K955643510(k) TraditionalCleared Mar 1, 199680-day reviewClass II21 CFR 892.1900

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Denoptix, Inc. · EGY Processor, Radiographic-Film, Automatic, Dental

Cleared on Mar 1, 1996 as substantially equivalent to K934949 (Orion Corporation Soredex, 1994) and 4 other predicates after an 80-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.

Decided: Mar 1, 1996
Review: 80 days
Class: Class II
Product code: EGY
Recalls: None
Predicates: 5

Its longest line of descent runs back 1 generation to K884621 (1989). 5 ancestors in all. 4 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK884621 DigiscanSiemens Medical Solutions USA, Inc. · 1989
This deviceK955643 Alara Imaging SystemDenoptix, Inc. · 1996
Descendant · cites it directly · 1 of its ownK071682 Crystalview T-Series Computed Radiography System, Models T110 (with…Alara, Inc. · 2007
Descendant · cites it directly · 1 of its ownK974619 Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998
Descendant · 2 generations on · 0 of its ownK102479 Alara T210 Computed Radiography SystemAlara, Inc. · 2011
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 4 of 4 · See all

K071682Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100…Alara, Inc. · 2007 · cites it directly1descendant
K974619Scanaray/CD-Dent Advanced Computerized X-Ray SystemAfp Imaging Corp. · 1998 · cites it directly1descendant
K102479Alara T210 Computed Radiography SystemAlara, Inc. · 2011 · 2 generations on0descendants
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
−1	K884621	Digiscan	Siemens Medical Solutions USA, Inc.	1989	—
0 (this device)	K955643	Alara Imaging System	Denoptix, Inc.	1996	—
+1	K071682	Crystalview T-Series Computed Radiography System, Models T110 (with Eraser)…	Alara, Inc.	2007	—
+1	K974619	Scanaray/CD-Dent Advanced Computerized X-Ray System	Afp Imaging Corp.	1998	—
+2	K102479	Alara T210 Computed Radiography System	Alara, Inc.	2011	—
+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
1998	1	0
1999	1	0
2007	1	0
2011	1	0

FIG. 1 — Lineage of K955643, 1989–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 EGY? 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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K934949	Digora Summary page 1 …, 1995 II. Names Device Names: ALARA Imaging System Primary Classification Name: Electrostatic X-ray Imaging System (90 IXK) II1. Predicate Devices * Digora device (K934949), marketed by Orion/Soredex; e DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.; ¢ Comp…	Orion Corporation Soredex	1994	—
*	K924459	Digiscan 2 Summary page 1 …ssification Name: Electrostatic X-ray Imaging System (90 IXK) II1. Predicate Devices * Digora device (K934949), marketed by Orion/Soredex; e DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.; ¢ Computed Radiogra&hy DMS CRT Image Consoles (K924012 and K923990), ma…	Siemens Medical Solutions USA, Inc.	1992	—
*	K884621	Digiscan Summary page 1 …Name: Electrostatic X-ray Imaging System (90 IXK) II1. Predicate Devices * Digora device (K934949), marketed by Orion/Soredex; e DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.; ¢ Computed Radiogra&hy DMS CRT Image Consoles (K924012 and K923990), marketed by Fu…	Siemens Medical Solutions USA, Inc.	1989	—
*	K924012	Fuji Computed Radiography HI-C653 DMS CRT Image Summary page 1 …, marketed by Orion/Soredex; e DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.; ¢ Computed Radiogra&hy DMS CRT Image Consoles (K924012 and K923990), marketed by Fuji Medical Systems USA, Inc. IV. Product Description The ALARA Imaging System is digital dental rad…	Fujifilm Medical System U.S.A., Inc.	1992	—
*	K923990	Fuji Computed Radiography HI-C652B DMS CRT Image Summary page 1 …y Orion/Soredex; e DIGISCAN 2 and DIGISCAN (K924459 and K884621), marketed by Siemens Medical Systems, Inc.; ¢ Computed Radiogra&hy DMS CRT Image Consoles (K924012 and K923990), marketed by Fuji Medical Systems USA, Inc. IV. Product Description The ALARA Imaging System is digital dental radiography sys…	Fujifilm Medical System U.S.A., Inc.	1992	—

Also cleared against K934949: 4 other devices →

What descends from it? (4)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071682	Crystalview T-Series Computed Radiography System, Models T110 (with Eraser) and T100…	Alara, Inc.	2007	1
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 2000	Digident, Ltd.	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?

None of the 5 ancestors has a recall.
Of its descendants, K071682 (Alara, Inc., 2007) has gone furthest, with 1 descendant of its own.
4 other devices also cite its predicate K934949.

How does its category compare?

All EGY devices

EGY Processor, Radiographic-Film, Automatic, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EGY

FDA has decided no EGY device since 2007.

Median 510(k) review, days · EGY

Too few EGY 510(k)s in any year since 2007 to give a median.

Recalls per year · EGY

No recall names EGY since 2007.

Adverse event reports per year · EGY

1in 2012

2007high 2 (2007) · low 0 (2008)2025

MAUDE reports naming product code EGY, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	2
2008	—	0
2009	—	1
2010	—	1
2011	—	0
2012	—	1
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

The ALARA Imaging System is indicated for use digital dental radiography system for using X-ray recording media (phosphor storage screens) for radiographic diagnostic intraoral and extraoral exposures providing interactive CRT retrieval, viewing and processing of stored computed radiographic images.

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/K955643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K955643: Alara Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955643

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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