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Invivo 784015

by Philips Ds North America LLC

Invivo 784015 is a Class II device made by Philips Ds North America LLC, cleared under FDA 510(k) K053610 on 19 Apr 2006 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00884838081550), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K053610

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884838081550 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK053610 Date19 Apr 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K053610 decided 19 Apr 2006 Active
  • FDA GUDID UDI-DI 00884838081550 listed 23 Sep 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-2769-2011 FDA Unclassified (pre-2012) initiated 1 Jun 2011

    PercuNav Tool Connection Unit may contain an electronic component that does not meet specification, which could cause registration difficulties and/or inaccurate instrument tracking.

    • Terminated Z-2219-2011 FDA Unclassified (pre-2012) initiated 1 Apr 2011

    The PercuNav Field Generator Stand could tip over during set up, during use, or during transport.

    • Terminated Z-0617-2011 FDA Unclassified (pre-2012) initiated 10 Nov 2010

    The protective cover over the tip of the MP008R-B Button Probe may fall off, causing the probe tip to damage the packaging and compromise the sterility of the probe.

Timeline

5 dated events

  1. Cleared FDA 510(k) K053610
  2. Recall initiated FDA recalls Z-0617-2011
  3. Recall initiated FDA recalls Z-2219-2011
  4. Recall initiated FDA recalls Z-2769-2011
  5. Listed FDA GUDID 00884838081550

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Invivo
Generic name
Stereotactic system application software
Model / reference
784015
Primary DI / UDI-DI
00884838081550
510(k) Number
FDA product code
JAK
GMDN term
Stereotactic system application software
Device class
Class II
Regulation number
892.1750
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Stereotactic system application software

Other devices from Philips Ds North America LLC

See all devices from Philips Ds North America LLC →

Properties

  • Serial number
Other properties (14, all answered No)