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)

HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM

K-Number: K972348 · 1997-07-24

ApplicantHewlett-Packard Co.
Decision Date1997-07-24
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hewlett-Packard Co.. It received FDA 510(k) clearance on 1997-07-24 under 510(k) number K972348. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM?

HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1997-07-24. The listed applicant is Hewlett-Packard Co.. The 510(k) number is K972348.

When did HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM receive FDA 510(k) clearance?

HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM received FDA 510(k) clearance on 1997-07-24, under 510(k) number K972348.

Who is the listed applicant for HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM?

The FDA 510(k) record lists Hewlett-Packard Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM?

The FDA product code for HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM is ITX.

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 Hewlett-Packard Co. 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.

K992543HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLEK993587HP M2376A DEVICE LINK SYSTEMK993169MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810AK992977HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504AK993516HP M2600A VIRIDIA TELEMETRY SYSTEMK993171HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A

View all 230 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑