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QVCAD System (Version 3.3)

by Qview Medical, Inc.

PMA P150043

QVCAD System (Version 3.3) is a medical device (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Qview Medical, Inc., approved under FDA PMA P150043 on 9 Nov 2016, active as of 11 Oct 2026.

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

PMA P150043↗

FDA record

Trust

Unverified

Source FDA PMA, synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPRL NumberP150043 Date9 Nov 2016DecidedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Trade name
Qvcad System
Generic name
Analyzer, medical image
PMA number
FDA product code
MYN
Device class
Class II
Regulation
21 CFR Part 892.2070
Advisory committee
Radiology
FDA decision
APRL

Devices cleared under P150043

8 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under P150043
UDI-DISize and differences
QVCAD System 3.3
Qview Medical, Inc.
3.3B630QVCS33 —On the market
QVCAD System 3.4
Qview Medical, Inc.
3.4B630QVCS34 —On the market
QVCAD System 3.4.2
Qview Medical, Inc.
3.4.2B630QVCS342 —On the market
QVCAD System 3.4.4
Qview Medical, Inc.
3.4.4B630QVCS344 —On the market
QVCAD System 3.4.6
Qview Medical, Inc.
3.4.6B630QVCS346 —No longer on the market
QVCAD System Installation Kit 10.10-3.4.3
Qview Medical, Inc.
10.10-3.4.3B630QVCSIK1010343 —On the market
QVCAD System Installation Kit 10.10-3.4.4
Qview Medical, Inc.
10.10-3.4.4B630QVCSIK1010344 —On the market
QVCAD System Installation Kit 12.02-3.4.6
Qview Medical, Inc.
12.02-3.4.6B630QVCSIK1202346 —No longer on the market

Similar devices

Other devices filed under FDA product code MYN (Analyzer, Medical Image).

Other devices from Qview Medical, Inc.

See all devices from Qview Medical, Inc. →