Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

AMERICAN MEDICAL OPTICS IMAGING SYS

K-Number: K842127 · 1984-09-07

ApplicantAmerican Medical Optics
Decision Date1984-09-07
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AMERICAN MEDICAL OPTICS IMAGING SYS is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Optics. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K842127. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMERICAN MEDICAL OPTICS IMAGING SYS?

AMERICAN MEDICAL OPTICS IMAGING SYS is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is American Medical Optics. The 510(k) number is K842127.

When did AMERICAN MEDICAL OPTICS IMAGING SYS receive FDA 510(k) clearance?

AMERICAN MEDICAL OPTICS IMAGING SYS received FDA 510(k) clearance on 1984-09-07, under 510(k) number K842127.

Who is the listed applicant for AMERICAN MEDICAL OPTICS IMAGING SYS?

The FDA 510(k) record lists American Medical Optics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMERICAN MEDICAL OPTICS IMAGING SYS?

The FDA product code for AMERICAN MEDICAL OPTICS IMAGING SYS is IYO.

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 American Medical Optics 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.

K860001BARRAQUER-KRUMEICH REFRACTIVE SETK851263AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOPK851264AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMASK851262AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMAK844150MEDICAL OPTICS PHACOEMULSIFICATION KITK843966ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS

View all 17 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, Inc.

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.

↑