CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
FDA 510(k) clearance K993645 · decided 1999-12-21
Clearance details
- K-number
- K993645
- Device name
- CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM
- Applicant
- Ge Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-28
- Decision date
- 1999-12-21
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- JAK
- Device class
- 2
- Regulation number
- 892.1750
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Milwaukee, WI, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ge Medical Systems
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BodyTom Elite (NL4000) (K253450) | NeuroLogica Corp., a Samsung Company | 2026-07-28 |
| CardIQ Suite (K253770) | GE Medical Systems SCS | 2026-07-21 |
| Enhanced Boundary for PCCT (K253560) | Ge Medical Systems, LLC | 2026-06-24 |
| Respiratory Gating for Scanners (2.1) (K253026) | Varian Medical Systems, Inc. | 2026-06-04 |
| Aquilion ONE (TSX-308A/TSX-306A) V2.0 (K253596) | Canon Medical Systems Corporation | 2026-05-20 |
| Spectral CT Verida Family (K253649) | Philips Medical Systems Technologies , Ltd. | 2026-03-27 |
| True Definition DL (K253686) | Ge Healthcare Japan Corporation | 2026-03-23 |
| CT Rembra RT; CT Areta RT; CT Rembra (K252992) | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-23 |
| Photonova Spectra, Photonova Spectra Select (K253520) | Ge Medical Systems, LLC | 2026-03-20 |
| SOMATOM X.cite; SOMATOM X.ceed (K253574) | Siemens Medical Solutions USA, Inc. | 2026-03-20 |
| Aquilion ServeSP (TSX-307B) V2.0 (K260078) | Canon Medical Systems Corporation | 2026-03-13 |
| Extremity CT Imaging System (K252249) | Mars Bioimaging , Ltd. | 2026-03-13 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare CT/e and HiSpeed X/i, families of computed tomography Systems with Gantry. T recall (Z-2224-2009) | GE Medical Systems, LLC | 2009-09-18 |
| Patient tables of CT systems with brand name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; recall (Z-0269-05) | General Electric Med Systems LLC | 2005-02-24 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR, 0146 (P870025/S011) | Ge Medical Systems, Inc. | 2012-10-10 |
| FETAL ACOUSTIC STIMULATOR (P870025/S010) | Ge Medical Systems, Inc. | 2011-10-12 |
| FETAL ACOUSTIC STIMULATOR (FAST) (P870025/S009) | Ge Medical Systems, Inc. | 2010-04-23 |
| FETAL ACOUSTIC STIMULATOR (P870025/S008) | Ge Medical Systems, Inc. | 2006-03-02 |
| COROMETRICS MODEL 146-FETAL ACOUSTIC STIMULATOR (P870025/S007) | Ge Medical Systems, Inc. | 2005-03-24 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S006) | Ge Medical Systems, Inc. | 2001-11-09 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S005) | Ge Medical Systems, Inc. | 1996-07-17 |
| COROMETRICS MODEL 146 FETAL ACOUSTIC STIMULATOR (P870025/S004) | Ge Medical Systems, Inc. | 1996-02-01 |