510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K130442Substantially Equivalent

Newtom Vgi and Newtom 5G

Qr S.r.l., Ormond Beach FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K130442 is the FDA 510(k) clearance record for NEWTOM VGI AND NEWTOM 5G, a class II device, cleared for Qr S.R.L. on under FDA product code OAS (X-Ray, Tomography, Computed, Dental). FDA's definition for product code OAS reads: "Produce cross-sectional diagnostic x-ray images of the intra-oral tissue and teeth". FDA records list one 510(k) clearance for Qr S.R.L. As of , FDA records show no recalls naming K130442.

Clearance record

Decision date
Received
(132 days to decision)
Product code
OAS X-Ray, Tomography, Computed, Dental
Regulation
21 CFR 892.1750
Device class
Class II
Review panel
Radiology
Applicant
Qr S.R.L. 110 E. Granada Blvd., Suite 207, Ormond Beach FL
510(k) summary
Statement
Third party review
No

Clearances, product code OAS

Trailing 12 months
11 clearances under product code OAS in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OAS, trailing twelve months
MonthClearances
November 20252
December 20250
January 20260
February 20261
March 20262
April 20261
May 20261
June 20262
July 20261
August 20260
September 20261
October 20260