Lung Image Analysis
FDA 510(k) K212494 · Pulmonx Corporation
510(k) numberK212494
Submission
- Device name
- Lung Image Analysis
- Applicant
- Pulmonx Corporation
Redwood City, CA, US - Received
- August 9, 2021
- Decision date
- September 2, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| 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 |
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| K180011 | Pulmonx Chartis Tablet ConsoleBZG · Traditional | 07/13/2018SE |
| K111764 | Chartis ConsoleBZG · Special | 11/10/2011SE |
| K111522 | Chartis Catheter Model CHR-CA-12.0CBI · Special | 09/29/2011SE |
| K083883 | Chartis CatheterCBI · Traditional | 06/25/2009SE |
| K083199 | Chartis ConsoleBZG · Traditional | 06/25/2009SE |
| K973191 | The Visualized Endotracheal Tube System or Vett SystemBTR · Traditional | 02/13/1998SE |
Questions and answers
When was Lung Image Analysis cleared by the FDA?
Lung Image Analysis (K212494) received a 510(k) decision of Substantially Equivalent on September 2, 2021, 24 days after the submission was received.
What is the product code of K212494?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.