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)

ERGO IMAGING SYSTEM

K-Number: K123408 · 2013-01-15

ApplicantDigirad Corp.
Decision Date2013-01-15
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ERGO IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Digirad Corp.. It received FDA 510(k) clearance on 2013-01-15 under 510(k) number K123408. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ERGO IMAGING SYSTEM?

ERGO IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-01-15. The listed applicant is Digirad Corp.. The 510(k) number is K123408.

When did ERGO IMAGING SYSTEM receive FDA 510(k) clearance?

ERGO IMAGING SYSTEM received FDA 510(k) clearance on 2013-01-15, under 510(k) number K123408.

Who is the listed applicant for ERGO IMAGING SYSTEM?

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

What is the FDA product code for ERGO IMAGING SYSTEM?

The FDA product code for ERGO IMAGING SYSTEM is IYX.

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 Digirad 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.

K100838ERGO IMAGING SYSTEMK083649CARDIUS 3 X-ACTK082904STASYS MOTION CORRECTION SOFTWAREK082368CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEMK070542CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMSK052430CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM

View all 16 devices →

Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation SafetyK2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLCK163687OLINDA EXMHermes Medical Solutions ABK160933Discovery NM 750b BopsyGE HealthcareK162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-K111791LUMAGEM MOLECULAR BREAST IMAGING SYSTEMGamma Medica-Ideas Incorporated

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.

↑