510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013897Substantially Equivalent

Solid State X-Ray Imaging Devices, Model Iris 20 and Iris 41 with Iris View

Bio-Scan, Inc., Stamford CT / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K013897 is the FDA 510(k) clearance record for SOLID STATE X-RAY IMAGING DEVICES, MODEL IRIS 20 AND IRIS 41 WITH IRIS VIEW, a class II device, cleared for Bio-Scan S.A on under FDA product code MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager)). FDA records list 7 510(k) clearances for Bio-Scan S.A, from to . As of , FDA records show no recalls naming K013897.

Clearance record

Decision date
Received
(179 days to decision)
Product code
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Bio-Scan S.A 153 Sanford Ln., Stamford CT
510(k) summary
Summary
Third party review
No

Clearances, product code MQB

Trailing 12 months
3 clearances under product code MQB in the twelve months to October 2026, June 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20262
July 20261
August 20260
September 20260
October 20260