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FDA 510(k)

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)

K-Number: K032113 · 2003-12-23

ApplicantChroma Vision Medical Systems, Inc.
Decision Date2003-12-23
Product CodeNOT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Chroma Vision Medical Systems, Inc.. It received FDA 510(k) clearance on 2003-12-23 under 510(k) number K032113. The device is classified under product code NOT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)?

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) is a medical device that received FDA 510(k) clearance on 2003-12-23. The listed applicant is Chroma Vision Medical Systems, Inc.. The 510(k) number is K032113.

When did ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) receive FDA 510(k) clearance?

ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) received FDA 510(k) clearance on 2003-12-23, under 510(k) number K032113.

Who is the listed applicant for ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)?

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

What is the FDA product code for ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)?

The FDA product code for ACIS (AUTOMATED CELLULAR IMAGING SYSTEM) is NOT.

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 Chroma Vision Medical 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.

K012138MODIFICATION TO ACIS (AUTOMATED CELLULAR IMAGING SYSTEM)K984188AUTOMATED CELLULAR IMAGING SYSTEM (ACIS)

Related Devices (Code: NOT)

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.

K260755OptraSCAN SystemOptrascan, Inc.K121033VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K121350VIRTUSO SYSTEM FOR IHC (DO-7)Ventana Medical Systems, Inc.K111755VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)Ventana Medical Systems, Inc.K111543VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)Ventana Medical Systems, Inc.K080564SCANSCOPE XT SYSTEMAperio Technologies

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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