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)

SYSTEM, PLANNING, TREATMENT

K-Number: K780948 · 1978-06-22

ApplicantEmi Therapy Systems, Inc.
Decision Date1978-06-22
Product CodeIWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYSTEM, PLANNING, TREATMENT is the device name listed in this FDA 510(k) record. The listed applicant is Emi Therapy Systems, Inc.. It received FDA 510(k) clearance on 1978-06-22 under 510(k) number K780948. The device is classified under product code IWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM, PLANNING, TREATMENT?

SYSTEM, PLANNING, TREATMENT is a medical device that received FDA 510(k) clearance on 1978-06-22. The listed applicant is Emi Therapy Systems, Inc.. The 510(k) number is K780948.

When did SYSTEM, PLANNING, TREATMENT receive FDA 510(k) clearance?

SYSTEM, PLANNING, TREATMENT received FDA 510(k) clearance on 1978-06-22, under 510(k) number K780948.

Who is the listed applicant for SYSTEM, PLANNING, TREATMENT?

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

What is the FDA product code for SYSTEM, PLANNING, TREATMENT?

The FDA product code for SYSTEM, PLANNING, TREATMENT is IWB.

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 Emi Therapy Systems, 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.

K781084THERAPAX 150AK780027ACCELERATOR, LINEAR, MED.K771817EMI THERAPY SIMULATORK771902EMI FOUR

Related Devices (Code: IWB)

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.

K250391Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™)Elekta Solutions ABK232854Leksell GammaPlan (LGP)Elekta Solutions ABK222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant)Elekta Solutions ABK203250TaiChiCOur United CorporationK203146Akesis Galaxy RTiAkesis, Inc.K200050Akesis Galaxy RTxAkesis, 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.

↑