P3T Abdomen
FDA 510(k) K082458 · Medrad, Inc.
510(k) numberK082458
Submission
- Device name
- P3T Abdomen
- Applicant
- Medrad, Inc.
Indianola, PA, US - Received
- August 26, 2008
- Decision date
- October 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Other 510(k)s with product code JAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
| K253450 | BodyTom Elite (NL4000)JAK · Traditional | NeuroLogica Corp., a Samsung Company | 07/28/2026SE |
| K253770 | CardIQ SuiteJAK · Traditional | GE Medical Systems SCS | 07/21/2026SE |
| K253560 | Enhanced Boundary for PCCTJAK · Traditional | Ge Medical Systems, LLC | 06/24/2026SE |
| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
| K253596 | Aquilion ONE (TSX-308A/TSX-306A) V2.0JAK · Traditional | Canon Medical Systems Corporation | 05/20/2026SE |
| K253649 | Spectral CT Verida FamilyJAK · Traditional | Philips Medical Systems Technologies , Ltd. | 03/27/2026SE |
| K253686 | True Definition DLJAK · Traditional | Ge Healthcare Japan Corporation | 03/23/2026SE |
| K252992 | CT Rembra RT; CT Areta RT; CT RembraJAK · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 03/23/2026SE |
| K253574 | SOMATOM X.cite; SOMATOM X.ceedJAK · Traditional | Siemens Medical Solutions USA, Inc. | 03/20/2026SE |
More from Siemens Medical Solutions USA, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K133023 | Jetstream XC 2.4/3.4; Jetstream XC 2.1/3.0; Jetstream SC 1.85; Jetstream SC 1.6MCW · Traditional | 08/27/2014SE |
| K130381 | Angiojet Ultra Power Pulse KitQEW · Traditional | 07/29/2013SE |
| K130637 | Jetstream XC 2.4/3.4 System; Jetstream XC 2.1/3.0 System; Jetstream SC 1.85 System…MCW · Special | 04/10/2013SE |
| K122916 | Jetstream Navitus L System Jeystream Navitus System Jetstream G3 SF System Jetstream SF…MCW · Special | 10/19/2012SE |
| K113363 | Angiojet Solent Dista Thrombectomy SetQEZ · Traditional | 06/06/2012SE |
| K113133 | Medrad Mark 7 Arterion (Pedestal System), (Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 12/15/2011SE |
| K113428 | Angiojet Ultra DVX Thrombectomy SetQEZ · Special | 12/02/2011SE |
| K112086 | Medrad Mark 7 Arterion (Pedestal System / Table Mount System), Medrad Mark 7 Arterion…DXT · Special | 10/14/2011SE |
| K111182 | Angiojet Solent Omni Thrombectomy SetQEZ · Special | 05/24/2011SE |
| K100798 | Medrad Intego PET Infusion System, Source Administration Set, Patient Adminstratin Set…FRN · Traditional | 06/23/2010SE |
Questions and answers
When was P3T Abdomen cleared by the FDA?
P3T Abdomen (K082458) received a 510(k) decision of Substantially Equivalent on October 17, 2008, 52 days after the submission was received.
What is the product code of K082458?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.