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)

PANOPTIC

K-Number: K121405 · 2012-12-20

ApplicantWelch Allyn, Inc.
Decision Date2012-12-20
Product CodeHKI
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

PANOPTIC is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K121405. The device is classified under product code HKI. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PANOPTIC?

PANOPTIC is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K121405.

When did PANOPTIC receive FDA 510(k) clearance?

PANOPTIC received FDA 510(k) clearance on 2012-12-20, under 510(k) number K121405.

Who is the listed applicant for PANOPTIC?

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

What is the FDA product code for PANOPTIC?

The FDA product code for PANOPTIC is HKI.

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 Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

View all 109 devices →

Related Devices (Code: HKI)

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.

K253176TearViewBeyond 700 Pty, Ltd.K251353Eyer 2Phelcom TechnologiesK252120Fundus On Phone Non Mydriatic (FOP NM-10)Remidio Innovative Solutions Private LimitedK250770Optina-4C (MHRC-C1N)Optina Diagnostics, Inc.K2436003nethra neo HD FA; 3nethra neo HDForus Health Pvt.LtdK250683Resolve Fundus CameraOptain Health, 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.

↑