510(k) Report

510(k) · Cleared

Cleared

Aztech 65 with CCD (Computer Controlled Density) Timer

K950667510(k) TraditionalCleared Apr 6, 199552-day reviewClass II21 CFR 872.1810

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

Chicago X-Ray Systems, Inc. · EAP Unit, X-Ray, Intraoral

Cleared on Apr 6, 1995 after a 52-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Apr 6, 1995
Review
52 days
Class
Class II
Product code
EAP
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2003: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950667 Aztech 65 with CCD (Computer Controlled Density) TimerChicago X-Ray Systems, Inc. · 1995
  2. Descendant · cites it directly · 1 of its ownK984524 Aztech 70Villa Sistemi Medicali S.P.A. · 1999
  3. Descendant · 2 generations on · 0 of its ownK030185 Endos AC/AcpVilla Sistemi Medicali S.P.A. · 2003

Most influential descendants

Showing 2 of 2 · See all
  • K984524Aztech 70Villa Sistemi Medicali S.P.A. · 1999 · cites it directly1descendant
  • K030185Endos AC/AcpVilla Sistemi Medicali S.P.A. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950667Aztech 65 with CCD (Computer Controlled Density) TimerChicago X-Ray Systems, Inc.1995—
+1K984524Aztech 70Villa Sistemi Medicali S.P.A.1999—
+2K030185Endos AC/AcpVilla Sistemi Medicali S.P.A.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200310
FIG. 1 — Lineage of K950667, 1995–2003Source: 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 EAP? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K984524Aztech 70Villa Sistemi Medicali S.P.A.19991

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, K984524 (Villa Sistemi Medicali S.P.A., 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All EAP devices

EAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EAP

1in 2012

2008: 12009: 12011: 12012: 1
2007high 1 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EAP

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

Recalls per year · EAP

3in 2012

2012: 3
2007high 3 (2012) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EAP

1in 2025

2007: 62008: 182009: 22018: 52019: 32021: 12022: 22023: 122025: 1
2007high 18 (2008) · low 0 (2010)2025

MAUDE reports naming product code EAP, 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—06
20081—018
20091—02
20100—00
20111—00
20121—30
20130—00
20140—00
20150—00
20160—00
20170—00
20180—05
20190—03
20200—00
20210—01
20220—02
20230—012
20240—00
20250—01
20260—0—

More from Chicago X-Ray Systems, Inc.

4 FDA decisions under this applicant name. See the company

  • K972968Rotograph PlusChicago X-Ray Systems, Inc. · 1997
  • K954565Explor-X (Azteh) HFChicago X-Ray Systems, Inc. · 1995
  • K931300Flash DentChicago X-Ray Systems, Inc. · 1994

Recent decisions in EAP

The EAP category page

  • K113360Medical Image Processing UnitHumanray Co,Ltd · 2012
  • K102573Provu (TM) Dental X-Ray SystemAdvanced Image Science, Inc. · 2011
  • K093453Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2009
  • K080738Dentron SensorDentron Systems, LLC · 2008
  • K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)Flow X-Ray Corp. · 2005

https://510kreport.com/device/K950667 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950667: Aztech 65 with CCD (Computer Controlled Density) Timer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950667

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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