Wilcor-Xr RP Medical Film

FDA 510(k) K834613 · Cea America Corp.

Substantially Equivalent

510(k) numberK834613

Submission

Device name
Wilcor-Xr RP Medical Film
Applicant
Cea America Corp.
Mchenry, IL, US
Received
December 20, 1983
Decision date
March 5, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IWZ – Film, Radiographic
Device class
Class I (low risk)
Regulation
21 CFR 892.1840
Specialty
Radiology

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K920539Orwo X-Ray FilmIWZ · Traditional Burkhart Roentgen Intl., Inc.06/30/1992SE
K884827Kodak Dental Barrier PacIWZ · Traditional Eastman Kodak Company01/30/1989SE
K862944Kodak CFT Film SO-141IWZ · Traditional Eastman Kodak Company08/12/1986SE
K862415Type 633 Computed Radiography (CR) FilmIWZ · Traditional Parexel Intl. Corp.07/01/1986SE
K860797Medical X-Ray FilmIWZ · Traditional India-America Trading Co.03/13/1986SE
K844554Belmont Autopan-Panoramic 098 Cephalometric-RadiogIWZ · Traditional Belmont Equipment Corp.02/21/1985SE

More from Belmont Equipment Corp.

510(k)DeviceDecision
K942525Medicount Deka Hematology AnalyzerGKZ · Traditional 06/05/1996SE
K834614Wilcor-Xr Rp-L Medical FilmIWZ · Traditional 03/05/1984SE
K834612Wilcor-Xr Rp-Og Medical FilmIWZ · Traditional 02/27/1984SE
K834611Singul-Xr RP Non Screen Med. FilmIWZ · Traditional 02/21/1984SE

Questions and answers

When was Wilcor-Xr RP Medical Film cleared by the FDA?

Wilcor-Xr RP Medical Film (K834613) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 76 days after the submission was received.

What is the product code of K834613?

The FDA product code is IWZ – Film, Radiographic, a Class I (low risk) device regulated under 21 CFR 892.1840.