510(k) · Cleared

Cleared

CT Scope

K974344510(k) TraditionalCleared Jun 3, 1998196-day reviewClass II21 CFR 892.1750

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Elscint, Inc. · JAK System, X-Ray, Tomography, Computed

Cleared on Jun 3, 1998 as substantially equivalent to K945512 (Elscint, Inc., 1995) and 3 other predicates after a 196-day review. Its family tree reaches back 1 generation to 1993.

Decided: Jun 3, 1998
Review: 196 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 4

Its longest line of descent runs back 1 generation to K930090 (1993). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK930090 HelicatElscint, Inc. · 1993
This deviceK974344 CT ScopeElscint, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K930090	Helicat	Elscint, Inc.	1993	—
0 (this device)	K974344	CT Scope	Elscint, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	1	0

FIG. 1 — Lineage of K974344, 1993–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (4)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K945512	HRSW Option for CT Twin Flash Summary page 1 …oint and angle of needle insertion externally to the gantry opening for convenience. 4. Predicate Devices R CT-Twin flash submitted in “HRSW Option for CT-Twin Flash” K945512. HeliCAT CT scanner, K930090 Precise Biopsy Localization by Computed Tomography, Radiology 118:603-607, March 1976 Toshiba Amer…	Elscint, Inc.	1995	—
*	K930090	Helicat Summary page 1 …rtion externally to the gantry opening for convenience. 4. Predicate Devices R CT-Twin flash submitted in “HRSW Option for CT-Twin Flash” K945512. HeliCAT CT scanner, K930090 Precise Biopsy Localization by Computed Tomography, Radiology 118:603-607, March 1976 Toshiba America Medical Systems Inc., Rea…	Elscint, Inc.	1993	—
*	K950972	Real-Time Reconstruction System Model TSXF-001A Summary page 1 …lization by Computed Tomography, Radiology 118:603-607, March 1976 Toshiba America Medical Systems Inc., Real time Reconstruction system option for Xpress/SX CT System, K950972, cleared on April 15, 1996. GE-YMS CT ProSpeed Family of CT Systems with ProSpeed Renaissance Options, K970600, cleared on April…	Toshiba America Medical Systems, In.C	1996	—
*	K970606	Computed Tomography X-Ray System Our OCR of the scanned summary read K970600, FDA’s number for Dermamend Foam Island Dressing (Dermarx Corp.). Corrected to the number one digit away that FDA lists under the company the summary names beside it.	GE Medical Systems	1997	—

Also cleared against K945512: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 4 ancestors has a recall.
3 other devices also cite its predicate K945512.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

Whole body Computed Tomography applications and specifically for interventional procedures that are performed on the CT table.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974344 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974344: CT Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974344

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026