510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K124049Substantially Equivalent

Deepview Digital Video Physiological Portable Imaging System

Spectralmd, Inc., Richardson TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K124049 is the FDA 510(k) clearance record for DEEPVIEW DIGITAL VIDEO PHYSIOLOGICAL PORTABLE IMAGING SYSTEM, a class II device, cleared for Spectralmd, Inc. on under FDA product code DPT (Probe, Blood-Flow, Extravascular). FDA records list 3 510(k) clearances for Spectralmd, Inc., from to . As of , FDA records show no recalls naming K124049.

Clearance record

Decision date
Received
(108 days to decision)
Product code
DPT Probe, Blood-Flow, Extravascular
Regulation
21 CFR 870.2120
Device class
Class II
Review panel
Cardiovascular
Applicant
Spectralmd, Inc. 1201 Richardson Dr., Suite 280, Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DPT

Trailing 12 months

FDA records hold no clearances under product code DPT in the trailing twelve months.

FDA records show no clearances under product code DPT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DPT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260