510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091558Substantially Equivalent

Biovision Digital Specimen Radiography System

Bioptics, Inc., Tucson AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091558 is the FDA 510(k) clearance record for BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM, a class II device, cleared for Bioptics, Inc. on under FDA product code MWP (Cabinet, X-Ray System). FDA records list 4 510(k) clearances for Bioptics, Inc., from to . As of , FDA records show no recalls naming K091558.

Clearance record

Decision date
Received
(50 days to decision)
Product code
MWP Cabinet, X-Ray System
Regulation
21 CFR 892.1680
Device class
Class II
Review panel
Radiology
Applicant
Bioptics, Inc. 3440 E. Britannia Dr., Tucson AZ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MWP

Trailing 12 months

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

FDA records show no clearances under product code MWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MWP, 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