Pfizer Pz-Ct Scanner
FDA 510(k) K801446 · Pfizer Medical Systems, Inc.
510(k) numberK801446
Submission
- Device name
- Pfizer Pz-Ct Scanner
- Applicant
- Pfizer Medical Systems, Inc.
Mchenry, IL, US - Received
- June 20, 1980
- Decision date
- July 28, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K803032 | Pfizer Pz-Slm Rad. Therapy Trtmt. Simul.KPQ · Traditional | 01/22/1981SE |
| K802532 | Pfizonic 300 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802531 | Pfizonic 200 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802530 | Pfizonic 250 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K802529 | Pfizonic 100 Ultrasound ScannerDXK · Traditional | 12/18/1980SE |
| K802528 | Pfizonic 150 Ultrasound ScannerIYO · Traditional | 12/18/1980SE |
| K800501 | Pfizer/As&E 0450 LocalizerJDX · Traditional | 04/10/1980SE |
| K781752 | Scanner, CT 0450JAK · Traditional | 11/03/1978SE |
| K780278 | Radiation Therapy Treat. Plan. Sys.JAD · Traditional | 03/02/1978SE |
| K772289 | Scanner, CT, 0400JAK · Traditional | 12/21/1977SE |
Questions and answers
When was Pfizer Pz-Ct Scanner cleared by the FDA?
Pfizer Pz-Ct Scanner (K801446) received a 510(k) decision of Substantially Equivalent on July 28, 1980, 38 days after the submission was received.
What is the product code of K801446?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.