Jamieson Jt-Crp Cine Film Processor

FDA 510(k) K913241 · Jamieson Film Co.

Substantially Equivalent

510(k) numberK913241

Submission

Device name
Jamieson Jt-Crp Cine Film Processor
Applicant
Jamieson Film Co.
Dallas, TX, US
Received
July 22, 1991
Decision date
September 24, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IXX – Processor, Cine Film
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1900
Specialty
Radiology

Other 510(k)s with product code IXX

510(k)DeviceApplicantDecision
K963334Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100IXX · Traditional Jamieson Film Co.09/11/1996SE
K915365AP-6CR Cineradiographic Film ProcessorIXX · Traditional The Allen Products Co.08/27/1992SE
K861928Sterile O. R. TowelIXX · Traditional Anago, Inc.06/09/1986SE
K850421Cine Radiographic Film Processor M-45CRIXX · Traditional The Allen Products Co.03/22/1985SE
K841431Radiographic Film Processor M-30CR &IXX · Traditional The Allen Products Co.07/06/1984SE

More from The Allen Products Co.

510(k)DeviceDecision
K970738Kodak Digital Science Cardiac Digital Acquisition UnitIZI · Traditional 05/07/1997SE
K971128CAP-35B Iii/Cine 275IXR · Traditional 04/28/1997SE
K963334Jamieson Model 2100 Cine Film Processor and Kodak Cineflure Processor Model 2100IXX · Traditional 09/11/1996SE
K960043Kodak Cardiology Digital Archive & Review SystemLLZ · Traditional 03/27/1996SE
K953563Vanguard XR-350 Cineangiogram ProjectorIZI · Traditional 10/05/1995SE

Questions and answers

When was Jamieson Jt-Crp Cine Film Processor cleared by the FDA?

Jamieson Jt-Crp Cine Film Processor (K913241) received a 510(k) decision of Substantially Equivalent on September 24, 1991, 64 days after the submission was received.

What is the product code of K913241?

The FDA product code is IXX – Processor, Cine Film, a Class II (moderate risk) device regulated under 21 CFR 892.1900.