510(k) · Cleared

Cleared

Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600

K052447510(k) AbbreviatedCleared Sep 21, 200514-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

Analogic Corp. · JAK System, X-Ray, Tomography, Computed

Cleared on Sep 21, 2005 as substantially equivalent to K033502 (Ge Medical Systems, LLC, 2003) and 3 other predicates after a 14-day review. Its family tree reaches back 4 generations to 1990.

Decided: Sep 21, 2005
Review: 14 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 4

Its longest line of descent runs back 4 generations to K903701 (1990). 7 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK903701 XpressToshiba America Medical Systems, In.C · 1990
3 generations backK982265 Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 1998 · Recalled
2 generations backK020385 CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101AToshiba America Medical Systems, In.C · 2002
1 generation backK022050 CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A…Toshiba America Medical Systems, In.C · 2002
This deviceK052447 Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600Analogic Corp. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K903701	Xpress	Toshiba America Medical Systems, In.C	1990	—
−3	K982265	Aquilion CT Scanner, Model TSX-101A	Toshiba America Medical Systems, In.C	1998	3
−2	K020385	CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A	Toshiba America Medical Systems, In.C	2002	—
−1	K022050	CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion…	Toshiba America Medical Systems, In.C	2002	—
0 (this device)	K052447	Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600	Analogic Corp.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2003	2	0

FIG. 1 — Lineage of K052447, 1990–2005Source: 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
*	K033502	Lightspeed 6.0 CT Scanner System Summary page 2 …e: System, X-ray, Tomography, Computed Reason for submission Reason for submission New Devices Comparison with predicates Predicate #1 K033502 GE Lightspeed 6.0 CT Scanner System Predicate #2 K030420 GE Lightspeed 5.0 CT Scanner System…	Ge Medical Systems, LLC	2003	—
*	K030420	Lightspeed 5.0 Computed Tomography System Summary page 2 …Reason for submission New Devices Comparison with predicates Predicate #1 K033502 GE Lightspeed 6.0 CT Scanner System Predicate #2 K030420 GE Lightspeed 5.0 CT Scanner System Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX Descript…	GE Medical Systems	2003	4
*	K020385	CGS-30A Multislice Upgrade Kit for Aquilion CT Scanner, Model TSX-101A Summary page 2 …redicate #1 K033502 GE Lightspeed 6.0 CT Scanner System Predicate #2 K030420 GE Lightspeed 5.0 CT Scanner System Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX Description of These Devices The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS…	Toshiba America Medical Systems, In.C	2002	—
*	K022050	CGS-31A Multislice Upgrade Kit for Aquilion CT Scanner. TSX-101A (Aquilion Advance Multi) Summary page 2 …3502 GE Lightspeed 6.0 CT Scanner System Predicate #2 K030420 GE Lightspeed 5.0 CT Scanner System Predicate #3 K020385, K022050 Toshiba Aquilion 16 CFX Description of These Devices The SyneRad IMPACT 60, SyneRad IMPACT 72 and Analogic AMS 1600 Multislic…	Toshiba America Medical Systems, In.C	2002	—

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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
3 of the 7 ancestors have a recall of any class.

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?

The SyneRad IMpact 60, SyneRad IMpact 72 and Analogic AMS1600 are

Computed Tomography X-ray Systems intended to produce images of the

head and whole body by computer reconstruction of X-ray transmission

data at different angle and planes. This device may include signal analysis

and display equipment, patient, and equipment supports, components

and accessories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052447 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052447: Synerad Impact 60, Synerad Impact 72 and Analogic AMS1600.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052447

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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