Explor-X (Azteh) HF

FDA 510(k) K954565 · Chicago X-Ray Systems, Inc.

Substantially Equivalent

510(k) numberK954565

Submission

Device name
Explor-X (Azteh) HF
Applicant
Chicago X-Ray Systems, Inc.
Wheeling, IL, US
Received
October 2, 1995
Decision date
October 27, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EAP – Unit, X-Ray, Intraoral
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1810
Specialty
Dental

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K093453Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.11/30/2009SE
K080738Dentron SensorEAP · Traditional Dentron Systems, LLC05/13/2008SE
K052422The Envision Intraoral Dental X-Ray Machines (Wall Mounted and Mobile)EAP · Special Flow X-Ray Corp.09/27/2005SE
K041385Modification to Computed Oral Radiology SystemEAP · Special Schick Technologies, Inc.06/07/2004SE
K960819Heliodent DSEAP · Traditional Pelton & Crane Co.03/29/1996SE
K960028Orthoralix SD2 & S Panoramic Dental X-Ray SystemEAP · Traditional Dentsply Intl.03/01/1996SE
K953936AtlantisEAP · Traditional Trophy Radiologie12/28/1995SE
K951734Lumix 70BEAP · Traditional Emix U.S.A., Inc.07/20/1995SE

More from Emix U.S.A., Inc.

510(k)DeviceDecision
K972968Rotograph PlusEHD · Traditional 10/08/1997SE
K950667Aztech 65 with CCD (Computer Controlled Density) TimerEAP · Traditional 04/06/1995SE
K931300Flash DentEHD · Traditional 03/21/1994SE

Questions and answers

When was Explor-X (Azteh) HF cleared by the FDA?

Explor-X (Azteh) HF (K954565) received a 510(k) decision of Substantially Equivalent on October 27, 1995, 25 days after the submission was received.

What is the product code of K954565?

The FDA product code is EAP – Unit, X-Ray, Intraoral, a Class II (moderate risk) device regulated under 21 CFR 872.1810.