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FDA 510(k)

ACU-RAY HF SERIES PORTABLE X-RAY UNIT

K-Number: K972204 · 1997-10-08

ApplicantSterne Equipment Co., Ltd.
Decision Date1997-10-08
Product CodeIZL
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACU-RAY HF SERIES PORTABLE X-RAY UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Sterne Equipment Co., Ltd.. It received FDA 510(k) clearance on 1997-10-08 under 510(k) number K972204. 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 ACU-RAY HF SERIES PORTABLE X-RAY UNIT?

ACU-RAY HF SERIES PORTABLE X-RAY UNIT is a medical device that received FDA 510(k) clearance on 1997-10-08. The listed applicant is Sterne Equipment Co., Ltd.. The 510(k) number is K972204.

When did ACU-RAY HF SERIES PORTABLE X-RAY UNIT receive FDA 510(k) clearance?

ACU-RAY HF SERIES PORTABLE X-RAY UNIT received FDA 510(k) clearance on 1997-10-08, under 510(k) number K972204.

Who is the listed applicant for ACU-RAY HF SERIES PORTABLE X-RAY UNIT?

The FDA 510(k) record lists Sterne Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACU-RAY HF SERIES PORTABLE X-RAY UNIT?

The FDA product code for ACU-RAY HF SERIES PORTABLE X-RAY UNIT is IZL.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sterne Equipment Co., Ltd. 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.

K003433NEURO-TRAIN III (3)K980158MYO-TRAIN V (5)K970155NEURO-TRAIN II (2)K931279ACU-RAYK883896NEUROTRAIN

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

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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