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Pedcat

by CurveBeam LLC

510(k) K113548

Pedcat is a medical device (FDA Class II; FDA product code JAK, System, X-Ray, Tomography, Computed) made by CurveBeam LLC, cleared under FDA 510(k) K113548 on 10 Apr 2012, 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 NumberK113548 Date10 Apr 2012ClearedStatusActive

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  • Withdrawn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
JAK
FDA applicant
Curvebeam, LLC
Device class
Class II
Regulation
21 CFR Part 892.1750
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K113548

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 K113548
UDI-DISize and differences
PedCAT 1000-115
CurveBeam LLC
1000-11500863152000300 —On the market
PedCAT 1000-230
CurveBeam LLC
1000-23000863152000317 —On the market

Similar devices

Other devices filed under FDA product code JAK (System, X-Ray, Tomography, Computed).

Other devices from CurveBeam LLC

  • Ossview

    Class IIa

  • PedCAT 1000-230

    Class II

  • PedCAT 1000-115

    Class II

  • CubeVue 3.6.0

    Class II

See all devices from CurveBeam LLC →