105MM Roll Film Fluorogr. Camera, #105

FDA 510(k) K810072 · Scientex Corp.

Substantially Equivalent

510(k) numberK810072

Submission

Device name
105MM Roll Film Fluorogr. Camera, #105
Applicant
Scientex Corp.
Mchenry, IL, US
Received
January 13, 1981
Decision date
February 12, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1620
Specialty
Radiology

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K945580DSP OptionIZJ · Traditional Philips Medical Systems (Cleveland), Inc.01/30/1995SE
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K896615Cine Camera Control Model PK2037IZJ · Traditional Perkins Mfg. Co.01/04/1990SE
K881688DTV-4114 Fluoroscopic Television CameraIZJ · Traditional Adac Laboratories05/18/1988SE
K853983Canon X-Ray 35MM Cine Camera CSI-35IZJ · Traditional Canon USA, Inc.10/16/1985SE
K812613Vidicam 200IZJ · Traditional Diversified P.A.12/08/1981SE
K810191Sircam 103IZJ · Traditional Siemens Corp.02/26/1981SE
K802132105MM Spot Film CameraIZJ · Traditional Instrumentation Camera, Inc.10/23/1980SE

Questions and answers

When was 105MM Roll Film Fluorogr. Camera, #105 cleared by the FDA?

105MM Roll Film Fluorogr. Camera, #105 (K810072) received a 510(k) decision of Substantially Equivalent on February 12, 1981, 30 days after the submission was received.

What is the product code of K810072?

The FDA product code is IZJ – Camera, X-Ray, Fluorographic, Cine Or Spot, a Class II (moderate risk) device regulated under 21 CFR 892.1620.