X-Ray Tube - Panobeam

FDA 510(k) K770345 · Thoro-Ray, Inc.

Substantially Equivalent

510(k) numberK770345

Submission

Device name
X-Ray Tube - Panobeam
Applicant
Thoro-Ray, Inc.
Mchenry, IL, US
Received
February 22, 1977
Decision date
March 8, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code EAP

510(k)DeviceApplicantDecision
K113360Medical Image Processing UnitEAP · Special Humanray Co,Ltd02/07/2012SE
K102573Provu (TM) Dental X-Ray SystemEAP · Traditional Advanced Image Science, Inc.06/30/2011SE
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
K954565Explor-X (Azteh) HFEAP · Traditional Chicago X-Ray Systems, Inc.10/27/1995SE

Questions and answers

When was X-Ray Tube - Panobeam cleared by the FDA?

X-Ray Tube - Panobeam (K770345) received a 510(k) decision of Substantially Equivalent on March 8, 1977, 14 days after the submission was received.

What is the product code of K770345?

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