510(k) Report

510(k) · Cleared

Cleared

Processor, Radiographic-Film, Automatic, Dental

K945682510(k) TraditionalCleared Feb 9, 199580-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

Gendex Corp. · EGY Processor, Radiographic-Film, Automatic, Dental

Cleared on Feb 9, 1995 after an 80-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it.

Decided
Feb 9, 1995
Review
80 days
Class
Class II
Product code
EGY
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared1995200020052010201520202025
  1. This deviceK945682 Processor, Radiographic-Film, Automatic, DentalGendex Corp. · 1995
  2. Descendant · cites it directly · 0 of its ownK992896 DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all
  • K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K945682Processor, Radiographic-Film, Automatic, DentalGendex Corp.1995—
+1K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
FIG. 1 — Lineage of K945682, 1995–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc.19990

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, K992896 (Dental X-Ray Support Systems, Inc., 1999) has gone furthest, with 0 descendants of its own.

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

2007: 22009: 12010: 12012: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—00
20090—01
20100—01
20110—00
20120—01
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Gendex Corp.

14 FDA decisions under this applicant name. See the company

  • K952598GX-Pan Panoramic Dental X-Ray SystemGendex Corp. · 1995
  • K935046GX-770 X-Ray Control, Model 46-404600G4Gendex Corp. · 1994
  • K925094Visualix Radiographic Image Detecting and ProcessGendex Corp. · 1993
  • K931001Oralix DCGendex Corp. · 1993
  • K932675GXP Dental X-Ray ProcessorGendex Corp. · 1993

Recent decisions in EGY

The EGY category page

  • K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)Dental X-Ray Support Systems, Inc. · 1999
  • K955825Smith S-100 Time & Temperature ControlSmith Companies Dental Products · 1996
  • K955643Alara Imaging SystemDenoptix, Inc. · 1996
  • K900156AP201 Dental X-Ray Film ProcessorAllied Photo Products Co., Inc. · 1990
  • K874118Model 410 Dental X-Ray Film ProcessorsDent-X Co. · 1987

https://510kreport.com/device/K945682 · printed Nov 6, 2026

Cite this page

510(k) Report. “K945682: Processor, Radiographic-Film, Automatic, Dental.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K945682

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026