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)

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67

K-Number: K092333 · 2010-10-27

ApplicantBioimagene, Inc.
Decision Date2010-10-27
Product CodeNQN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 is the device name listed in this FDA 510(k) record. The listed applicant is Bioimagene, Inc.. It received FDA 510(k) clearance on 2010-10-27 under 510(k) number K092333. The device is classified under product code NQN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67?

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 is a medical device that received FDA 510(k) clearance on 2010-10-27. The listed applicant is Bioimagene, Inc.. The 510(k) number is K092333.

When did PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 receive FDA 510(k) clearance?

PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 received FDA 510(k) clearance on 2010-10-27, under 510(k) number K092333.

Who is the listed applicant for PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67?

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

What is the FDA product code for PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67?

The FDA product code for PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 is NQN.

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 Bioimagene, 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.

K080910PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITSK062756PATHIAM IMAGING SOFTWARE FOR HER2/NEU

Related Devices (Code: NQN)

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.

K130515VIRTUOSO SYSTEM FOR IHC ER (SPI)Ventana Medical Systems, Inc.K121516VIRTUOSO SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K122143VIRTUOSO SYSTEM FOR IHC PR (1E2) BENCHMARK ULTRA STAINERVentana Medical Systems, Inc.K111872VIRTUOSO SYSTEM FOR IHC P53 (DO-7)Ventana Medical Systems, Inc.K111869VIRTUOSO SYSTEM FOR IHC PR (IE2)Ventana Medical Systems, Inc.K073677SCANSCOPE XT SYSTEMAperio Technologies

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.

↑