Beta I & Beta II

FDA 510(k) K811082 · Porta Ray, Inc.

Substantially Equivalent

510(k) numberK811082

Submission

Device name
Beta I & Beta II
Applicant
Porta Ray, Inc.
Walker, MI, US
Received
April 21, 1981
Decision date
May 21, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IZL – System, X-Ray, Mobile
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1720
Specialty
Radiology

Other 510(k)s with product code IZL

510(k)DeviceApplicantDecision
K260236XliteIZL · Traditional Gemss Healthcare Co., Ltd.08/03/2026SE
K253058Portable DR Imaging SystemIZL · Traditional Shantou Institute of Ultrasonic Instruments Co.…06/18/2026SE
K260085RAYMO Mobile X-ray System (Model: RAYMO)IZL · Traditional DRGEM Corporation05/14/2026SE
K253185Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray SystemIZL · Traditional Carestream Health03/11/2026SE
K253244AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini)IZL · Traditional Poskom Co., Ltd.02/23/2026SE
K250976Airbile-100IZL · Traditional Poskom Co., Ltd.12/19/2025SE
K251710Mobile X-ray unit (!M1)IZL · Traditional Solutions For Tomorrow AB10/24/2025SE
K243864BONX805IZL · Traditional Bontech Co., Ltd.09/12/2025SE
K251443PromoIZL · Traditional DRGEM Corporation08/22/2025SE
K251223HnX-P1, HnX-PBIZL · Traditional H&abyz Co., Ltd.08/04/2025SE

More from H&abyz Co., Ltd.

510(k)DeviceDecision
K864339Porta Ray Model 325IZO · Traditional 12/15/1986SE
K810276Alpha I and Alpha IIIZL · Traditional 03/11/1981SE
K792665PixieIZL · Traditional 01/29/1980SE

Questions and answers

When was Beta I & Beta II cleared by the FDA?

Beta I & Beta II (K811082) received a 510(k) decision of Substantially Equivalent on May 21, 1981, 30 days after the submission was received.

What is the product code of K811082?

The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.