Intrex VSK Interoral Dental X-Ray Unit

FDA 510(k) K931486 · Keystone X-Ray, Inc.

Substantially Equivalent

510(k) numberK931486

Submission

Device name
Intrex VSK Interoral Dental X-Ray Unit
Applicant
Keystone X-Ray, Inc.
Neptune Township, NJ, US
Received
March 24, 1993
Decision date
November 23, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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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
K954565Explor-X (Azteh) HFEAP · Traditional Chicago X-Ray Systems, Inc.10/27/1995SE

More from Chicago X-Ray Systems, Inc.

510(k)DeviceDecision
K930925Intrex Interoral Dental X-Ray UnitEAP · Traditional 07/13/1993SE
K883354Variable KV Intrex VSK 60 - 90 KVPEAP · Traditional 12/21/1988SE
K812217Fluoro Automatic Brightness SysJAA · Traditional 09/16/1981SE

Questions and answers

When was Intrex VSK Interoral Dental X-Ray Unit cleared by the FDA?

Intrex VSK Interoral Dental X-Ray Unit (K931486) received a 510(k) decision of Substantially Equivalent on November 23, 1993, 244 days after the submission was received.

What is the product code of K931486?

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