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FDA 510(k)

BETA I & BETA II

K-Number: K811082 · 1981-05-21

ApplicantPorta Ray, Inc.
Decision Date1981-05-21
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BETA I & BETA II is the device name listed in this FDA 510(k) record. The listed applicant is Porta Ray, Inc.. It received FDA 510(k) clearance on 1981-05-21 under 510(k) number K811082. The device is classified under product code IZL. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BETA I & BETA II?

BETA I & BETA II is a medical device that received FDA 510(k) clearance on 1981-05-21. The listed applicant is Porta Ray, Inc.. The 510(k) number is K811082.

When did BETA I & BETA II receive FDA 510(k) clearance?

BETA I & BETA II received FDA 510(k) clearance on 1981-05-21, under 510(k) number K811082.

Who is the listed applicant for BETA I & BETA II?

The FDA 510(k) record lists Porta Ray, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETA I & BETA II?

The FDA product code for BETA I & BETA II is IZL.

Other records listing Porta Ray, Inc. 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.

K864339PORTA RAY MODEL 325K810276ALPHA I AND ALPHA IIK792665PIXIE

Related Devices (Code: IZL)

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.

K260236XLITEGEMSS HEALTHCARE CO., LTD.K253058Portable DR Imaging SystemShantou Institute of Ultrasonic Instruments Co., Ltd.K260085RAYMO Mobile X-ray System (Model: RAYMO)DRGEM CorporationK253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemCarestream HealthK253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)Poskom Co., Ltd.K250976Airbile-100Poskom Co., Ltd.

Official Source

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

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