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Ray 1 SV403

by Swift Medical, Inc.

Ray 1 SV403 is a Class II device made by Swift Medical, Inc., cleared under FDA 510(k) K251678 on 24 Feb 2026 and listed in FDA GUDID since 18 Apr 2022 (UDI-DI 00627987231151), active as of 23 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K251678

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK251678 Date24 Feb 2026DecidedStatusActive
United StatesGUDID listing Number00627987231151 UDI-DI Date18 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K251678 decided 24 Feb 2026 Active
  • FDA GUDID UDI-DI 00627987231151 listed 18 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00627987231151
  2. Cleared FDA 510(k) K251678

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ray 1
Generic name
Infrared thermography system
Model / reference
SV403
Primary DI / UDI-DI
00627987231151
510(k) Number
FDA product code
QJF, FXN
GMDN term
Infrared thermography system
Device class
Class II
Regulation number
878.4550, 878.4160
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared thermography systemFluorescence wound imaging unit

Similar devices

Other devices filed under FDA product code FXN.

Other devices from Swift Medical, Inc.

See all devices from Swift Medical, Inc. →

Properties

  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)