Film Processor, Automatic

FDA 510(k) K770783 · General Electric Co.

Substantially Equivalent

510(k) numberK770783

Submission

Device name
Film Processor, Automatic
Applicant
General Electric Co.
Mchenry, IL, US
Received
May 2, 1977
Decision date
May 10, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
EGY – Processor, Radiographic-Film, Automatic, Dental
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1900
Specialty
Radiology

Other 510(k)s with product code EGY

510(k)DeviceApplicantDecision
K992896DXSS Automatic X-Ray Film Processor, (Models #S: 512, 1530, 812, 830)EGY · Traditional Dental X-Ray Support Systems, Inc.09/03/1999SE
K955825Smith S-100 Time & Temperature ControlEGY · Traditional Smith Companies Dental Products04/05/1996SE
K955643Alara Imaging SystemEGY · Traditional Denoptix, Inc.03/01/1996SE
K945682Processor, Radiographic-Film, Automatic, DentalEGY · Traditional Gendex Corp.02/09/1995SE
K900156AP201 Dental X-Ray Film ProcessorEGY · Traditional Allied Photo Products Co., Inc.05/14/1990SE
K874118Model 410 Dental X-Ray Film ProcessorsEGY · Traditional Dent-X Co.11/06/1987SE
K811211Yoshida Ap 100EGY · Traditional Kaycor Intl., Ltd.06/16/1981SE
K771433Auto. Devel. Unit Foo Dental X-RayEGY · Traditional Ada Products Co., Inc.08/19/1977SE

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Questions and answers

When was Film Processor, Automatic cleared by the FDA?

Film Processor, Automatic (K770783) received a 510(k) decision of Substantially Equivalent on May 10, 1977, 8 days after the submission was received.

What is the product code of K770783?

The FDA product code is EGY – Processor, Radiographic-Film, Automatic, Dental, a Class II (moderate risk) device regulated under 21 CFR 892.1900.