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FDA 510(k)

DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM

K-Number: K124049 · 2013-04-18

ApplicantSpectralmd, Inc.
Decision Date2013-04-18
Product CodeDPT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Spectralmd, Inc.. It received FDA 510(k) clearance on 2013-04-18 under 510(k) number K124049. The device is classified under product code DPT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM?

DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2013-04-18. The listed applicant is Spectralmd, Inc.. The 510(k) number is K124049.

When did DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM receive FDA 510(k) clearance?

DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM received FDA 510(k) clearance on 2013-04-18, under 510(k) number K124049.

Who is the listed applicant for DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM?

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

What is the FDA product code for DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM?

The FDA product code for DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM is DPT.

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 Spectralmd, 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.

K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0

Related Devices (Code: DPT)

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.

K233076Laser Speckle Imaging System (RFLSI CZW)Rwd Life Science Co., Ltd.K163339SPECTRALMD DEEPVIEW WOUND IMAGING SYSTEM 2.0Spectralmd, Inc.K152749moorLDI2-IR Infrared laser Doppler imager, moorLDI2-HIR High Resolution Infrared laser Doppler imager, moorLDI2-VR Visible Red laser Doppler imagerMoor Instruments, Ltd.K123216AIMAGO EASYLDI MICROCIRCULATION CAMERA (STAND PLUS CAMERA ARM), AIMAGO EASY LDI STAND, INCLUDING 4-WHEELED STAND BASE ANAimago SAK122943MOORFLPI-2 FULL-FIELD LASER PERFUSION IMAGERMoor Instruments, Ltd.K121429AIMAGO EASYLDI MICROCIRCULATION CAMERAAimago SA

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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