510(k) · Cleared

Cleared

DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)

K992896510(k) TraditionalCleared Sep 3, 19997-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

Dental X-Ray Support Systems, Inc. · EGY Processor, Radiographic-Film, Automatic, Dental

Cleared on Sep 3, 1999 as substantially equivalent to K945682 (Gendex Corp., 1995) after a 7-day review. Its family tree reaches back 1 generation to 1995.

Decided: Sep 3, 1999
Review: 7 days
Class: Class II
Product code: EGY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K945682 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK945682 Processor, Radiographic-Film, Automatic, DentalGendex Corp. · 1995
This deviceK992896 DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K945682	Processor, Radiographic-Film, Automatic, Dental	Gendex Corp.	1995	—
0 (this device)	K992896	DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)	Dental X-Ray Support Systems, Inc.	1999	—

FIG. 1 — Lineage of K992896, 1995–1999Source: 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? (1)

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
*	K945682	Processor, Radiographic-Film, Automatic, Dental Summary page 1 …425-640-2176 08/06/99 DXSS Automatic X-ray Film Processor Film Processor Dental Automatic Radiographic Film Processor (Per 21 CFR section 892.1900) Gendex Processor K945682 02/09/95 Dental automatic radiographic film processor The DXSS Automatic X-ray Film Processor is an automatic radiographic film…	Gendex Corp.	1995	—

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?

Its one ancestor has no recall.

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 DXSS Automatic X-ray Film Processor is an automatic radiographic film processor, a diagnostic device intended to be used to develop, fix, wash, and dry automatically and continuously film exposed for medical purposes. This is the sole purpose of this device.

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/K992896 · printed Nov 6, 2026

Cite this page

510(k) Report. “K992896: DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992896

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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