510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K133209Substantially Equivalent

Foresee (4C) Imaging System

Diagnostic Photonics, Inc., Philedelphia PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133209 is the FDA 510(k) clearance record for FORESEE (4C) IMAGING SYSTEM, a class II device, cleared for Diagnostic Photonics, Inc. on under FDA product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)). FDA's definition for product code NQQ reads: "This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging". FDA records list one 510(k) clearance for Diagnostic Photonics, Inc. As of , FDA records show no recalls naming K133209.

Clearance record

Decision date
Received
(151 days to decision)
Product code
NQQ System, Imaging, Optical Coherence Tomography (Oct)
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Diagnostic Photonics, Inc. 1835 Market St., 29th Floor, Philedelphia PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NQQ

Trailing 12 months
3 clearances under product code NQQ in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code NQQ, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260