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)

NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.

K-Number: K931657 · 1993-07-27

ApplicantVictoreen, Inc.
Decision Date1993-07-27
Product CodeKPT
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. is the device name listed in this FDA 510(k) record. The listed applicant is Victoreen, Inc.. It received FDA 510(k) clearance on 1993-07-27 under 510(k) number K931657. The device is classified under product code KPT. It was reviewed by the RA advisory panel. Product code KPT falls under the category of In Vitro Diagnostics, which includes laboratory reagents and diagnostic test kits. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.?

NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. is a medical device that received FDA 510(k) clearance on 1993-07-27. The listed applicant is Victoreen, Inc.. The 510(k) number is K931657.

When did NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. receive FDA 510(k) clearance?

NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. received FDA 510(k) clearance on 1993-07-27, under 510(k) number K931657.

Who is the listed applicant for NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.?

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

What is the FDA product code for NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL.?

The FDA product code for NUCLEAR ASSOCIATES MODEL 34-070 BRACHYTHERAPY CAL. is KPT. This falls under the In Vitro Diagnostics category.

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 Victoreen, 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.

K982937MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBERK974112VACUDAP, MODEL 2000, 2001K973960MODEL 37-185K964952VERIDOSE V (FIVE), MODEL NUMBER 37-705K964785VERIDOSE DIODESK971382PRONE BREAST POSITIONING BOARD, MODEL #37-018

View all 40 devices →

Related Devices (Code: KPT)

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.

K192199CRC PC Smart Chamber K1Capintec, Inc.K162394CRC-77tHRCapintec, Inc.K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWCapintec, Inc.K090296ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336Biodex Medical Systems, Inc.K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSCapintec, Inc.K042746PET-DOSEComecer S.R.L.

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.

↑