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FDA 510(k)

X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R

K-Number: K871116 · 1987-05-14

ApplicantX-Cel X-Ray Corp.
Decision Date1987-05-14
Product CodeIYH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel X-Ray Corp.. It received FDA 510(k) clearance on 1987-05-14 under 510(k) number K871116. The device is classified under product code IYH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R?

X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R is a medical device that received FDA 510(k) clearance on 1987-05-14. The listed applicant is X-Cel X-Ray Corp.. The 510(k) number is K871116.

When did X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R receive FDA 510(k) clearance?

X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R received FDA 510(k) clearance on 1987-05-14, under 510(k) number K871116.

Who is the listed applicant for X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R?

The FDA 510(k) record lists X-Cel X-Ray Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R?

The FDA product code for X-CEL X-RAY MODELS ORT90W, ORT90M AND ORT90R is IYH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing X-Cel X-Ray Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993958IDX-60 INTRAORAL X-RAYK930699M6-MK811230X-CELL X-RAY #'S P-75W/P-75M

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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