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Myray- HYPERION X5

by CEFLA s.c.

510(k) K152162

Myray- HYPERION X5 is a Class II device made by CEFLA s.c., cleared under FDA 510(k) K152162 on 24 Dec 2015, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK152162 Date24 Dec 2015ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MUH
Device class
Class II
Regulation
21 CFR Part 872.1800
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Devices cleared under K152162

2 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 K152162
UDI-DISize and differences
myray hyperion X5 (2D)
CEFLA SOCIETA' COOPERATIVA
XHYPEX5 / hyperion X5 (2D)08033837930914 —On the market
NewTom GO (2D)
CEFLA SOCIETA' COOPERATIVA
XNEWTGO / NewTom GO (2D)08033837931317 —On the market

Similar devices

Other devices filed under FDA product code MUH (System, X-Ray, Extraoral Source, Digital).

Other devices from CEFLA s.c.

See all devices from CEFLA s.c. →