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)

SCANDIPLAN - VERSION 338

K-Number: K914926 · 1992-05-28

ApplicantScanditronix, Inc.
Decision Date1992-05-28
Product CodeKPQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SCANDIPLAN - VERSION 338 is the device name listed in this FDA 510(k) record. The listed applicant is Scanditronix, Inc.. It received FDA 510(k) clearance on 1992-05-28 under 510(k) number K914926. The device is classified under product code KPQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCANDIPLAN - VERSION 338?

SCANDIPLAN - VERSION 338 is a medical device that received FDA 510(k) clearance on 1992-05-28. The listed applicant is Scanditronix, Inc.. The 510(k) number is K914926.

When did SCANDIPLAN - VERSION 338 receive FDA 510(k) clearance?

SCANDIPLAN - VERSION 338 received FDA 510(k) clearance on 1992-05-28, under 510(k) number K914926.

Who is the listed applicant for SCANDIPLAN - VERSION 338?

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

What is the FDA product code for SCANDIPLAN - VERSION 338?

The FDA product code for SCANDIPLAN - VERSION 338 is KPQ.

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 Scanditronix, 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.

K934303RFA A-300K942092DPD-3K925133DPD-510 THERAPEUTIC RADIATION DOSIMETERK904753DIOLASEK900434MM-22 MICROTRON, MM50 MICROTRONK843366SUPERPETT

View all 7 devices →

Related Devices (Code: KPQ)

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.

K132045ADVANTAGESIM MD WITH CT ATLAS-BASED CONTOURING AND RE-PLANNING OPTIONSGe Hungary KftK101038RAD II SIMULATOR, RAD II KV IMAGER, DUAL RAD II KV IMAGERAcceletronics Digital Imaging, LLCK090706ONCENTRA SIMULATION 2.3Nucletron CorporationK083591IKOENGELO, VERSION 2Ikoetech, LLCK072445INTEGRATED BRACHYTHERAPY UNIT - DIGITALNucletron Corp.K061006IKOENGELOIkoetech, LLC

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.

↑