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)

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100

K-Number: K973642 · 1997-11-21

ApplicantInstrumentarium Imaging, Inc.
Decision Date1997-11-21
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentarium Imaging, Inc.. It received FDA 510(k) clearance on 1997-11-21 under 510(k) number K973642. 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 ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100?

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 is a medical device that received FDA 510(k) clearance on 1997-11-21. The listed applicant is Instrumentarium Imaging, Inc.. The 510(k) number is K973642.

When did ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 receive FDA 510(k) clearance?

ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 received FDA 510(k) clearance on 1997-11-21, under 510(k) number K973642.

Who is the listed applicant for ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100?

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

What is the FDA product code for ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100?

The FDA product code for ORTHOPANTOMOGRAPH OP100 AND ORTHOCEPH OC100 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 Instrumentarium Imaging, 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.

K002472DELTA 32 AND DELTA 32 TACTK001928SIGMAK000976DIAMOND (MAMMOGRAPHIC X-RAY SYSTEM)K001171DELTA 16 TACTK955411DELTA 16K925987INSTRUMENTARIUM MEGA4 HT

View all 24 devices →

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.

↑