X-Cel X-Ray Models ORT90W, ORT90M and ORT90R

FDA 510(k) K871116 · X-Cel X-Ray Corp.

Substantially Equivalent

510(k) numberK871116

Submission

Device name
X-Cel X-Ray Models ORT90W, ORT90M and ORT90R
Applicant
X-Cel X-Ray Corp.
Crystal Lake, IL, US
Received
March 19, 1987
Decision date
May 14, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IYH – Generator, Dermatological (Grenz Ray), Therapeutic X-Ray
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5900
Specialty
Radiology

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Questions and answers

When was X-Cel X-Ray Models ORT90W, ORT90M and ORT90R cleared by the FDA?

X-Cel X-Ray Models ORT90W, ORT90M and ORT90R (K871116) received a 510(k) decision of Substantially Equivalent on May 14, 1987, 56 days after the submission was received.

What is the product code of K871116?

The FDA product code is IYH – Generator, Dermatological (Grenz Ray), Therapeutic X-Ray, a Class II (moderate risk) device regulated under 21 CFR 892.5900.