A.X.T. Spotfilm Device

FDA 510(k) K882492 · Applied X-Ray Technologies, Inc.

Substantially Equivalent

510(k) numberK882492

Submission

Device name
A.X.T. Spotfilm Device
Applicant
Applied X-Ray Technologies, Inc.
Westminster, CO, US
Received
June 16, 1988
Decision date
July 21, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IXL – Device, Spot-Film
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1670
Specialty
Radiology

Other 510(k)s with product code IXL

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K111304Optima XR120IXL · Special Ge Medical Systems, LLC07/19/2011SE
K964806MD-1835IXL · Traditional Fischer Imaging Corp.03/04/1997SE
K950317Advantx 1824 Spotfilm DeviceIXL · Traditional GE Medical Systems02/08/1995SE
K940386Kodak Automixer III Integrated, Kodak Automixer III 180 LPIXL · Traditional Eastman Kodak Company08/17/1994SE
K942367Axt 1400 Spotfilm DeviceIXL · Traditional Applied X-Ray Technologies, Inc.06/06/1994SE
K924593Diagnost 76 Family*R/F Systems - Release 4.4IXL · Traditional Philips Medical Systems, Inc.11/24/1992SE
K902403Elite R/F Spot Film DriveIXL · Traditional Rms Div.08/01/1990SE
K902146SFD-035 Spot Film DeviceIXL · Traditional Rms Div.05/31/1990SE
K88158914X14 Multiformat Spot Filmer, No. 6650.400IXL · Traditional Continental X-Ray Corp.07/18/1988SE
K842184Spot-Film Device 8835IXL · Traditional General Electric Co.07/17/1984SE

More from General Electric Co.

510(k)DeviceDecision
K972966Axt 150M Manual Collimator (Axt 150M)IZX · Traditional 08/21/1997SE
K942367Axt 1400 Spotfilm DeviceIXL · Traditional 06/06/1994SE

Questions and answers

When was A.X.T. Spotfilm Device cleared by the FDA?

A.X.T. Spotfilm Device (K882492) received a 510(k) decision of Substantially Equivalent on July 21, 1988, 35 days after the submission was received.

What is the product code of K882492?

The FDA product code is IXL – Device, Spot-Film, a Class II (moderate risk) device regulated under 21 CFR 892.1670.