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NA PACC-GS30-HDx

by Machnet B.V.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB318PACCGS30HDX1 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
MRI system coil, radio-frequency
Model / Ref / Catalog
PACC-GS30-HDx
Primary DI / UDI-DI
B318PACCGS30HDX1
510(k) Number
FDA Product Code
MOS
GMDN Term
MRI system coil, radio-frequency
Device Class
Class II
Regulation Number
892.1000
GUDID distribution status
In Commercial Distribution

Related devices

Category: MRI system coil, radio-frequency

Cleared under the same submission (K012491)

Other devices from Machnet B.V.

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No