Precise Position

FDA 510(k) K203514 · Philips Healthcare (Suzhou) Co., Ltd.

Substantially Equivalent

510(k) numberK203514

Submission

Device name
Precise Position
Applicant
Philips Healthcare (Suzhou) Co., Ltd.
Suzhou, CN
Received
November 30, 2020
Decision date
June 17, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JAK – System, X-Ray, Tomography, Computed
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1750
Specialty
Radiology

Other 510(k)s with product code JAK

510(k)DeviceApplicantDecision
K253836FCT iStream Phase 2JAK · Traditional Fujifilm Corporation09/04/2026SE
K253450BodyTom Elite (NL4000)JAK · Traditional NeuroLogica Corp., a Samsung Company07/28/2026SE
K253770CardIQ SuiteJAK · Traditional GE Medical Systems SCS07/21/2026SE
K253560Enhanced Boundary for PCCTJAK · Traditional Ge Medical Systems, LLC06/24/2026SE
K253026Respiratory Gating for Scanners (2.1)JAK · Traditional Varian Medical Systems, Inc.06/04/2026SE
K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional Canon Medical Systems Corporation05/20/2026SE
K253649Spectral CT Verida FamilyJAK · Traditional Philips Medical Systems Technologies , Ltd.03/27/2026SE
K253686True Definition DLJAK · Traditional Ge Healthcare Japan Corporation03/23/2026SE
K252992CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional Philips Healthcare (Suzhou) Co., Ltd.03/23/2026SE
K253574SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional Siemens Medical Solutions USA, Inc.03/20/2026SE

More from Siemens Medical Solutions USA, Inc.

510(k)DeviceDecision
K252992CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional 03/23/2026SE
K260519Smart Fit TorsoCardiac 1.5TMOS · Special 03/20/2026SE
K242329CT Collaboration LiveLLZ · Traditional 11/18/2024SE
K232491CT 5300JAK · Traditional 05/03/2024SE
K233600Smart Fit Knee 3.0TMOS · Traditional 02/05/2024SE
K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS · Traditional 09/01/2023SE
K223311Philips CT 3500JAK · Traditional 12/22/2022SE
K212441Philips Incisive CTJAK · Traditional 04/27/2022SE
K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS · Traditional 12/01/2021SE
K211168Philips Incisive CT on TrailerJAK · Traditional 11/22/2021SE

Questions and answers

When was Precise Position cleared by the FDA?

Precise Position (K203514) received a 510(k) decision of Substantially Equivalent on June 17, 2021, 199 days after the submission was received.

What is the product code of K203514?

The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.