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)

MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS

K-Number: K043557 · 2005-01-13

ApplicantPanoramic Corp.
Decision Date2005-01-13
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Panoramic Corp.. It received FDA 510(k) clearance on 2005-01-13 under 510(k) number K043557. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS?

MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS is a medical device that received FDA 510(k) clearance on 2005-01-13. The listed applicant is Panoramic Corp.. The 510(k) number is K043557.

When did MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS receive FDA 510(k) clearance?

MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS received FDA 510(k) clearance on 2005-01-13, under 510(k) number K043557.

Who is the listed applicant for MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS?

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

What is the FDA product code for MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS?

The FDA product code for MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS is EHD.

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 Panoramic Corp. 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.

K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayK110371ENCOMPASS HF100- EAGLE PANORAMIC/CEPHALOMETRIC X-RAYK943532PANORAMIC CORPORATION HDLXK882436LASER - 1000K870236PANORAMIC X-RAY MODEL PC-1000

Related Devices (Code: EHD)

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.

K260795Hand-held Dental X-ray System (HyperLight-M)Changzhou Sifary Medical Technology Co., Ltd.K260367Portable Dental X-ray System Model PDX novaPDX Co., Ltd.K253864NOMAD Pro 3Dental Imaging Technologies CorporationK252110Dental X-RAY Unit (AJX200)Guangzhou Ajax Medical Equipment Co., Ltd.K254018Portable Dental X-ray Device (GT-1)Guilin Refine Medical Instrument Co., Ltd.K252909Diagnostic X-Ray Equipment Model POCT22Ningbo Runyes Medical Instrument 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.

↑