MD-1835

FDA 510(k) K964806 · Fischer Imaging Corp.

Substantially Equivalent

510(k) numberK964806

Submission

Device name
MD-1835
Applicant
Fischer Imaging Corp.
Addison, IL, US
Received
November 29, 1996
Decision date
March 4, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K882492A.X.T. Spotfilm DeviceIXL · Traditional Applied X-Ray Technologies, Inc.07/21/1988SE
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

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Questions and answers

When was MD-1835 cleared by the FDA?

MD-1835 (K964806) received a 510(k) decision of Substantially Equivalent on March 4, 1997, 95 days after the submission was received.

What is the product code of K964806?

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